BD AutoShield Duo 329515Recalls & reported problems

Summary

The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00382903295159), received between Jan 9, 2018 and Sep 25, 2026 — classified as 20 injuries, 188 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (69 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 208 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906112 ↗
• MalfunctionSep 25, 2026Misconnection

  Facility ¿ XXXX System.This facility has called in via voice message a PIR for the Autoshield Duo pen needles Item # 329515 Lot # 4164033. The issue with the pen needle per voice mail is ¿ when the pen needle is placed onto the pen, the pen needle keeps turning and does not stop. It is like the treading is striped. Found 6 pen needles with this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896056 ↗
• MalfunctionSep 25, 2026Misconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896050 ↗
• MalfunctionSep 25, 2026Misconnection

  Facility ¿ XXXX System.This facility has called in via voice message a PIR for the Autoshield Duo pen needles Item # 329515 Lot # 4164033. The issue with the pen needle per voice mail is ¿ when the pen needle is placed onto the pen, the pen needle keeps turning and does not stop. It is like the treading is striped. Found 6 pen needles with this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895704 ↗
• MalfunctionSep 25, 2026Misconnection

  Facility ¿ XXXX System.This facility has called in via voice message a PIR for the Autoshield Duo pen needles Item # 329515 Lot # 4164033. The issue with the pen needle per voice mail is ¿ when the pen needle is placed onto the pen, the pen needle keeps turning and does not stop. It is like the treading is striped. Found 6 pen needles with this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895570 ↗
• MalfunctionSep 24, 2026Break; Defective Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886237 ↗
• MalfunctionSep 9, 2026Failure to Deliver; Defective Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695526 ↗
• MalfunctionSep 9, 2026Leak/Splash; Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681012 ↗
• MalfunctionAug 13, 2025Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED THAT NEEDLE WAS CLOGGING DURING THE INJECTION LOT # 4711012 CATALOG # 329515 DATE OF EVENT: UNKNOWN SAMPLE STATUS: YES. (B)(6) 01AUGUST2025. UPDATE FOR CASE # (B)(4). LOT # 4311012.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793316 ↗
• MalfunctionJul 9, 2025Break; Break

  PATIENT NEEDED INSULIN. WAS SCREWING THE NEEDLE ONTO THE INSULIN PEN. THE NEEDLE POPPED AND FELL APART IN MY HAND. THE PART WAS THE EMBECTA AUTOSHIELD DUTO 0.3MM X5MM EXP 2027-12-31, LOT 4311015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458765 ↗
• MalfunctionJun 10, 2025Defective Device; Defective Device

  ACCOUNT - (B)(6). SKU# 329515 LOT # 4193027 QUANTITY - UNKNOWN. COMPLAINT - YESTERDAY WE HAD TO PULL LOT NUMBERS 4193027 AND 4164021 FOR SAP # (B)(4) BECAUSE THERE WAS A SAFETY EVENT THAT OCCURRED WITH THE INSULIN NEEDLES. DURING THE EVENT IT WAS DISCOVERED THAT THE NEEDLES WERE NOT RETRACTING. THERE WERE SEVERAL NEEDLES TESTED AND ALL OF THEM SEEM TO BE DOING THE SAME EXACT THING. I WANTED TO INFORM YOU ALL SO THAT YOU CAN REACH OUT TO ANYONE WHO MAY BE IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177905 ↗
• MalfunctionMar 28, 2025Misconnection; Failure to Deliver; Misconnection; Failure to Deliver

  CONSUMER REPORTED NEEDLE CLOG DURING PRIMING. HE STATED THAT THE PEN JAMS. CONSUMER DOES NOT RE-USE. LOT #: 4131014 CATALOG #: 329515 DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719929 ↗
• MalfunctionMar 17, 2025Misconnection; Misconnection

  FACILITY ¿XXXX SYSTEM. THIS FACILITY HAS CALLED IN VIA VOICE MESSAGE A PIR FOR THE AUTOSHIELD DUO PEN NEEDLES ITEM # 329515 LOT # 4164033. THE ISSUE WITH THE PEN NEEDLE PER VOICE MAIL IS ¿ WHEN THE PEN NEEDLE IS PLACED ONTO THE PEN, THE PEN NEEDLE KEEPS TURNING AND DOES NOT STOP.. IT IS LIKE THE TREADING IS STRIPED. FOUND 6 PEN NEEDLES WITH THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618526 ↗
• MalfunctionFeb 26, 2025Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

  THE INCIDENT TOOK PLACE IN THE PATIENTS HOME. HOME HEALTH CARE AID STATED, SHE WAS TOLD BY THE AID WHO WORKED THE SHIFT BEFORE HER, THE NON-PATIENT END GOT STUCK IN THE INSULIN PEN AFTER GIVING THE PATIENT AN INJECTION. THE HOME HEALTH AID AFTER BEING TOLD ABOUT THE INCIDENT, STABBED HER FINGER WITH THE NON-PATIENT END THAT WAS STICKING OUT OF THE INSULIN PEN. STATED, THE NEEDLE WAS USED AND ASKED IF BLOOD COULD TRAVEL FROM THE NON-PATIENT END TO HER FINGER THAT WAS "STUCK". HOME HEALTH AID DID NOT CONFIRM IF BLOOD WAS ON THE NON-PATIENT END BEFORE STICKING HER FINGER. DECLINED TO SEND BACK THE SAMPLES, STATED, SHE DOES NOT FEEL COMFORTABLE PACKING UP THE INSULIN PEN WITH NEEDLE STICKING OUT OF IT BUT WAS OKAY WITH TOUCHING IT AFTER SHE WAS WARNED BY THE PREVIOUS AID, THERE WAS A NEEDLE THAT HAD BROKEN OFF AND WAS STICKING OUT FROM THE INSULIN PEN. STATED, SHE WENT TO HER DOCTOR AND GOT A SHOT JUST TO BE SAFE. STATED, SHE WILL EMAIL A PHOTO OF INSULIN PEN. I PROVIDED HER THE EMAIL ADDRESS AND CASE NUMBER. LOT: 4131014. CATALOG: UNKNOWN-PER HCP, "AUTO SHIELD DUO" WAS BEING USED. DATE OF EVENT: 2025-02-02. SAMPLE: NO.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21471262 ↗
• MalfunctionFeb 24, 2025Break; Break

  MATERIAL # 329515 MATERIAL DESCRIPTION - PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA MATERIAL LOT# - 4164034 COMPLAINT DESCRIPTION ¿ PLEASE BE ADVISED THAT ALL NEEDLES FROM LOT 4164034 ARE MALFUNCTIONING. WHEN ATTEMPTING TO PLACE ON PEN THE SPRINGS POPPED OFF THE NURSES TRIED OTHERS FROM A DIFFERENT LOT # WITH NO INCIDENT. NOTE: ATTACH IS THE PHOTOS AND MAIL THAT WAS SHARED BY THE CUSTOMER FOR FURTHER REFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454493 ↗
• MalfunctionFeb 24, 2025Break; Break

  ACCOUNT - XXXXX PHARMACY ITEM# 329515, LOT: 4073006, MFG: 3/31/24, EXP: 03/31/27. COMPLAINT - "I AM CONTACTING YOU DUE TO A SAFETY EVENT WE HAD WITH THE BD AUTOSHIELD DUO. ONE OF OUR NURSING STAFF WAS ADMINISTERING INSULIN TO A PATIENT AND WHEN SHE WENT TO TAKE OFF THE ATTACHED NEEDLE AFTER GIVING THE INSULIN, PART OF THE NEEDLE REMAINED IN THE PEN. THE SAFETY ACTION ON THE TOP OF THE NEEDLE APPEARS TO HAVE FUNCTIONED PROPERLY, BUT PART OF THE NEEDLE BROKE OFF AND REMAINED IN THE PEN. "X

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446990 ↗
• MalfunctionJan 30, 2025Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED NEEDLE CLOG DURING PRIMING AND DURING INJECTION. HE SAID THAT THERE IS NO INSULIN FLOW. LOT#: 4008235, CATALOG#: 320550, DATE OF EVENT: UNKNOWN, SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273523 ↗
• MalfunctionJan 13, 2025Misconnection; Defective Device; Misconnection; Defective Device

  MATERIAL # UNKNOWN. MATERIAL DESCRIPTION - UNKNOWN. MATERIAL LOT# - 4008246. COMPLAINT DESCRIPTION ¿ REACHING OUT TO YOU WITH SEVERAL CONCERNS REGARDING THE AUTOSHIELD DUO- I RECEIVED THIS RECENT REPORT: DANGEROUS SITUATION OCCURRING DURING ADMINISTRATION OF 40 UNITS OF LANTUS. NURSE DIALED UP 40 UNITS OF LANTUS, HAD GIVEN 14 UNITS WHEN THE PLUNGER STOPPED AT 26 UNITS. NURSE CAME OUT FOR HELP. WE TRIED ANOTHER FRESH NEEDLE, BUT THE PLUNGER WOULD NOT DEPRESS. REMOVED THE NEEDLE FROM PEN AND DISCOVERED THE METAL NEEDLE WAS DISLODGED IN THE PEN TIP ALMOST CAUSING A NEEDLE STICK. NURSE GRABBED ANOTHER PEN TO ADMINISTER THE REMAINING 26 UNITS TO PATIENT, AFTER 15 UNITS WERE ADMINISTERED THE PEN PLUNGER STOPPED AT 11 UNIT MARK, NEEDLE WAS REMOVED AND WE DISCOVERED THE NEEDLE BENT INSIDE THE NEEDLE CAP. NEW CAP WAS REPLACED ON THE SAME PEN AND NURSE WAS ABLE TO GIVE THE PATIENT THE REMAINING 11 UNITS. THIS IS HAPPENING OVER AND OVER AGAIN WITH THE NEW NEEDLES THAT WERE REPLACED ABOUT 4 MONTHS AGO. I AM NOT SURE IF THIS IS A DEVICE ISSUE OR RELATED TO TRAINING AND EDUCATION, BUT REPORTING THIS TO YOU. WE DO HAVE A SAMPLE TO RETURN FROM LOT #4008246. WE HAVE HAD OTHER EXPERIENCES OVER THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137234 ↗
• MalfunctionDec 9, 2024Leak/Splash; Leak/Splash

  MATERIAL # UNKNOWN MATERIAL DESCRIPTION - UNKNOWN MATERIAL LOT# - UNKNOWN COMPLAINT DESCRIPTION ¿ PLEASE REFER THE ATTACHMENT THAT WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20883601 ↗
• MalfunctionDec 5, 2024Break; Defective Device; Break; Defective Device

  I HAVE THE NEEDLE RELATED TO THIS EVENT. THIS WAS REPORTED TO THE FDA ON 11/4 AS REPORT # (B)(4) "THE BD AUTOSHIELD DUO INSULIN NEEDLE (LOT 4008246, EXP 01/2027) MALFUNCTIONED AND EXPLODED ON THE PEN, SENDING A SPRING AND THE RED NEEDLE HOLDER FLYING ONTO THE FLOOR. NO PATIENT OR STAFF WERE HARMED IN THE INCIDENT." I ALSO HAVE 2 NEEDLES AND THE PEN THAT WERE INVOLVED IN THE FOLLOWING EVENT. THIS WAS ALSO REPORTED TO FDA ON 11/4, AS REPORT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855257 ↗
• MalfunctionNov 22, 2024Misconnection; Defective Device; Misconnection; Defective Device

  MATERIAL # UNKNOWN MATERIAL DESCRIPTION - UNKNOWN MATERIAL LOT# - 4008246 COMPLAINT DESCRIPTION ¿ REACHING OUT TO YOU WITH SEVERAL CONCERNS REGARDING THE AUTOSHIELD DUO- I RECEIVED THIS RECENT REPORT: DANGEROUS SITUATION OCCURRING DURING ADMINISTRATION OF 40 UNITS OF LANTUS. NURSE DIALED UP (B)(4) UNITS OF LANTUS, HAD GIVEN (B)(4) UNITS WHEN THE PLUNGER STOPPED AT (B)(4) UNITS. NURSE CAME OUT FOR HELP. WE TRIED ANOTHER FRESH NEEDLE, BUT THE PLUNGER WOULD NOT DEPRESS. REMOVED THE NEEDLE FROM PEN AND DISCOVERED THE METAL NEEDLE WAS DISLODGED IN THE PEN TIP ALMOST CAUSING A NEEDLE STICK. NURSE GRABBED ANOTHER PEN TO ADMINISTER THE REMAINING (B)(4) UNITS TO PATIENT, AFTER 15 UNITS WERE ADMINISTERED THE PEN PLUNGER STOPPED AT 11 UNIT MARK, NEEDLE WAS REMOVED AND WE DISCOVERED THE NEEDLE BENT INSIDE THE NEEDLE CAP. NEW CAP WAS REPLACED ON THE SAME PEN AND NURSE WAS ABLE TO GIVE THE PATIENT THE REMAINING (B)(4) UNITS. THIS IS HAPPENING OVER AND OVER AGAIN WITH THE NEW NEEDLES THAT WERE REPLACED ABOUT 4 MONTHS AGO. I AM NOT SURE IF THIS IS A DEVICE ISSUE OR RELATED TO TRAINING AND EDUCATION, BUT REPORTING THIS TO YOU. WE DO HAVE A SAMPLE TO RETURN FROM LOT # 4008246. WE HAVE HAD OTHER EXPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759375 ↗
• MalfunctionNov 12, 2024Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  MATERIAL # 329515. MATERIAL DESCRIPTION - PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA. MATERIAL LOT# - 4032897. COMPLAINT DESCRIPTION: WE ARE HAVING SOME ISSUES WITH MFG#329515 LOT#4032897. I HAVE TWO PATIENT SAFETY REPORTS FOR THIS PRODUCT. PLEASE SEE DETAILS BELOW. WE ARE TRYING TO DETERMINE WHAT THE BEST COURSE OF ACTION IS FOR STAFF MOVING FORWARD. THANKS, (B)(4). THE PATIENT HAD 40 UNITS OF LONG ACTING INSULIN DUE. RN PROCEEDED TO ATTACH A AUTOSHIELD DUO NEEDLE TO THE HUB OF THE RESVOGLAR KWIKPEN. RN PRIMED THE NEEDLE WITH 2 UNITS AND THEN TURNED THE DIAL TO 40 AND DOUBLE SIGNED WITH ANOTHER RN. PRIMARY RN PROCEEDED TO GIVE THE RESVOGLAR KWIKPEN AND WHEN INJECTING THE PATIENT, THE NEEDLE PIERCED THE SKIN AND THE DIAL WAS PUSHED TO 20 UNITS WHEN IT WOULD NOT PUSH ANY FURTHER. PRIMARY RN REPEATED THE STEPS OF PRIMING ANOTHER NEEDLE TO GIVE REMAINING 20 UNITS OF INSULIN BUT STILL WOULD NOT ADMINISTER. WHEN TAKING OFF THE SECOND NEEDLE, THE RN WAS SPRAYED WITH INSULIN DUE TO PRESSURE BUILD-UP IN THE INSULIN CHAMBER. CHARGE RN AND PHARMACIST WAS NOTIFIED AND REMAINING 20 UNITS OF RESVOGLAR INSULIN WAS GIVEN USING A NEW RESVOGLAR KWIKPEN. NO IMAGES WERE PROVIDED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665259 ↗
• MalfunctionNov 12, 2024Failure to Deliver; Defective Device; Failure to Deliver; Defective Device

  MATERIAL # 329515. MATERIAL DESCRIPTION - PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA. MATERIAL LOT# - 4032897. COMPLAINT DESCRIPTION: WE ARE HAVING SOME ISSUES WITH MFG#329515 LOT#4032897. I HAVE TWO PATIENT SAFETY REPORTS FOR THIS PRODUCT. PLEASE SEE DETAILS BELOW. WE ARE TRYING TO DETERMINE WHAT THE BEST COURSE OF ACTION IS FOR STAFF MOVING FORWARD. THANKS, (B)(6). PT NEEDED A DOSE OF THE LONG ACTING INSULIN FROM THE REZVOGLAR KWIKPEN. SCREWED ON THE AUTOSHIELD NEEDLE, PRIMED AND TWISTED TO THE AMOUNT TO GIVE. WHEN GIVING THE PEN WOULD NOT GIVE ALL THE INSULIN DIALED TO GIVE. TOOK NEEDLE OFF AND SCREWED ON A NEW NEEDLE, PRIMED AND ATTEMPTED TO GIVE THE REST. PEN STILL WOULD NOT GIVE ALL THE INSULIN. UNSCREWED THAT NEEDLE AND NOTICED THERE WAS A NEEDLE STUCK IN THE RUBBER STOPPER OF THE KWIKPEN. THE ORIGINAL AUTOSHIELD NEEDLE WAS BENT AND THE SECOND WAS MISSING. SHOWED THE KWIKPEN TO THE PHARMACIST AND WAS DISPOSED OF PROPERLY. A NEW PEN WAS REQUESTED FROM PHARMACY. PROVIDER AND BEDSIDE NURSE WAS NOTIFIED. PATIENT WAS AWARE OF THE SITUATION. (B)(6). THE PATIENT HAD 40 UNITS OF LONG ACTING INSULIN DUE. RN PRCEEDED TO ATTACH A AUTOSHIELD DUO NEEDLE TO THE HUB OF THE RESVOGLAR KWIKPEN. RN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665054 ↗
• MalfunctionNov 11, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED FINDING THE AUTOSHIELD DUO PEN NEEDLES WILL NOT PRIME 24 PEN NEEDLES FROM THIS BOX. 2ND BOX WITH ISSUES SAME LOT NUMBER DC. LOT # 4008235. CATALOG# 329515. DATE OF EVENT UNKNOWN. SAMPLE STATUS AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658427 ↗
• MalfunctionNov 8, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED WHEN TAKING INJECTION, THE FLOW WILL STOP MIDWAY. STATED, SHE HAS TO USE A SECOND PEN NEEDLE TO COMPLETE THE INJECTION. STATED, THIS ISSUE HAS OCCURRED A LOT TIMES, (EXACT COUNT NOT AVAILABLE). LOT: 3069559. CATALOG: 329515. DATE OF EVENT: UNKNOWN. SAMPLES: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641745 ↗