Alaris 2865Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,404 adverse event reports that list this exact device (DI 10885403928659), received between Nov 27, 2017 and Mar 11, 2026 — classified as 30 injuries, 1,374 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (609 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,404 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Labelling, Instructions for Use or Training Problem; Application Network Problem

  IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, SEVERAL PATIENTS WERE MERGED IN EPIC. HOWEVER, BOTH PRIMARY IDS REMAINED ADMITTED IN THE SYSTEM AND CONTINUED TO SHARE THE SAME VISIT ID IN PYXIS. AS A RESULT, ONE OF THE PRIMARY ID AND VISIT ID COMBINATIONS HAD TO BE MANUALLY DISCHARGED. THE CUSTOMER WAS SEEKING TO UNDERSTAND WHY THE MERGE MESSAGE DID NOT CORRECTLY RESOLVE THE DUPLICATE PATIENT ACCOUNTS IN PYXIS. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567197 ↗
• MalfunctionNov 7, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A CCE SITE (COVERED UNDER ENTERPRISE LIC.) SYSTEM WAS UNDER CRITICAL OVERRIDE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23504358 ↗
• MalfunctionNov 5, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A CCE SITE (COVERED UNDER ENTERPRISE LIC.) THE MEDICATION DISPENSE MESSAGE TYPE WAS WRONG. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473413 ↗
• MalfunctionFeb 25, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: GOOD MORNING, I APOLOGISE FOR ASKING, I'LL TELL YOU THE PROBLEM STRAIGHT AWAY, I'VE BEEN USING YOUR INSULIN NEEDLES FOR MORE THAN 20 YEARS AND LATELY I'M FINDING SOME OF THEM CLOGGED, MORE FREQUENTLY THAN IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18774950 ↗
• MalfunctionDec 14, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: VOICE MESSAGE CALLER. USING BD PEN NEEDLES NOTHING COMING OUT OF NEEDLE - FINDING THE NPE TO BE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325362 ↗
• MalfunctionDec 4, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO PRIME. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED WHEN USING WITH HER NOVOLOG PEN, NOT ALL PEN NEEDLES CLOG DURING FLOW CHECK. NOVO INFORMED BD NEEDLES ARE NOT THE CORRECT PRODUCT TO USE WITH NOVO PEN. NEEDLE MIGHT HAVE DAMAGED HER PEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18264190 ↗
• MalfunctionNov 30, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS NOT WORKING. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: VOICE MESSAGE CALLER. USING BD PEN NEEDLES NOTHING COMING OUT OF NEEDLE - FINDING THE PEN TO BE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238729 ↗
• MalfunctionNov 21, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLE ONE NEEDLE WAS UNABLE TO PRIME. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: STATED, SHE PRIMED 2 UNITS STATED, SHE TRIED A SECOND PEN NEEDLE THAT WORKED WHEN PRIMING. CONSUMER REPORTED BD ULTRA FINE PEN NEEDLE NANO LOT # 3101673 FOUND 1 PEN NEEDLE CLOG - DURING FLOW CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188310 ↗
• MalfunctionNov 8, 2023Failure to Prime; Failure to Prime

  IT WAS REPORTED THE BD NANO¿ 2ND GEN PEN NEEDLE WOULD NOT PRIME. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN PRIMING, NO INSULIN FLOWS. STATED, SHE WILL TEST 2 OR 4 UNITS PRIOR TO INJECTION STATED, IF THE FIRST PEN NEEDLE DOES NOT WORK, SHE WILL TRY A SECOND PEN NEEDLE AND THAT WILL WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093180 ↗
• MalfunctionNov 2, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO PRIME. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED DURING THE FLOW CHECK OF LAST 2 BOXES 320122 FOUND 10-15 PEN NEEDLES EACH BOX THAT CLOGGED. INFORMED CALLER OF PROPER NON PATIENT END PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18061272 ↗
• MalfunctionNov 2, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO PRIME. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED DURING THE FLOW CHECK OF LAST 2 BOXES 320122 FOUND 10-15 PEN NEEDLES EACH BOX THAT CLOGGED. INFORMED CALLER OF PROPER NON PATIENT END PLACEMENT. VERBATIM: CONSUMER REPORTED DURING THE FLOW CHECK OF LAST 2 BOXES 320122 FOUND 10-15 PEN NEEDLES EACH BOX THAT CLOGGED. INFORMED CALLER OF PROPER NON PATIENT END PLACEMENT. DC LOT # UNKNOWN - FIRST BOX; LOT # 3017796 CURRENT BOX ; CATALOG# 320122 = 2 BOXES. FOLLOW UP FROM THE VERBATIM = LOT # UNKNOWN - FIRST BOX; LOT # 3017796 CURRENT BOX; CATALOG# 320122 = 2 BOXES; DATE OF EVENT UNKNOWN; SAMPLE STATUS DISCARD. HOPING THIS HELPS DC; DATE OF EVENT UNKNOWN; SAMPLE STATUS DISCARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18060395 ↗
• MalfunctionOct 31, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT DURING THE USE OF 16 BD NANO¿ ULTRA-FINE¿ PEN NEEDLES THE MEDICATION WOULD NOT INJECT. THE FOLLOWING WAS REPORTED BY THE CONSUMER: CONSUMER REPORTED FINDING FROM THIS BOX ONLY 16 PEN NEEDLES THAT WOULD NOT INJECT THE TRESEBA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044743 ↗
• MalfunctionOct 27, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 OF THE BD NANO¿ 2ND GEN PEN NEEDLE WERE UNABLE TO INJECT INSULIN. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: WIFE OF CONSUMER REPORTED FOUND 3 PEN NEEDLES FROM THIS SUPPLY CLOG DURING INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022881 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G THE CAP WAS DIFFICULT TO ATTACH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING HARD TIME PLACING THE PEN NEEDLES ONTO SISTER PEN. ASKED CALLER TO REVIEW THE NON PATIENT END SHE STATED THEY ARE ALL BENT. INFORMED CALLER OF PROPER PLACEMENT OF NON PATIENT END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007873 ↗
• MalfunctionOct 11, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THE BOX OF BD NANO¿ 2ND GEN PEN NEEDLE WAS LABELED INCORRECTLY. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: RECEIVED VOICEMAIL FROM PHARMACIST STATING A CONSUMER RETURNED A BOX OF PEN NEEDLES THAT HAD WRONG PRODUCT INSIDE. STATED, THE CATALOG NUMBER ON ONE OF BOXES READS, 320122 BUT 320550 WAS FOUND INSIDE PHARMACIST STATED, SHE TOOK BACK ALL THREE BOXES AND REPLACED THEM WITH BD MINI PEN NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916950 ↗
• MalfunctionOct 3, 2023Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLE IS WAS UNABLE TO PRIME. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE NEEDLES TO CLOG DURING FLOW CHECK. CALLER STATED REUSES, BUT, SAYS THE SAMPLES RETURNING COULD NOT BE USED AT ALL. CLOGGED DURING FLOW CHECK. INFORMED OF NON PATIENT END PLACEMENT AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865646 ↗
• MalfunctionSep 1, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLE THERE WAS NO INSULIN FLOW. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17671037 ↗
• MalfunctionAug 31, 2023Separation Problem; Separation Problem

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G THE OUTER SHIELD DID NOT PROPERLY DETACH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE OUTER COVER TO FALL OFF THE NEEDLE HUB WHEN PLACED INTO HER TRAVEL SHARPS CONTINER. SHE TRANSFERED THE SMALLER CONTAINER TO THE LARGER SHARPS CONTAINTER AND PRICKED HER FINGER A FEW TIMES. NO MEDICAL ATTENTION NEEDED. JUST A STICK UNDER SKIN NO BLOOD. INFORMED CALLER TO LEAVE THE SHARPS IN CONTAINER NEVER REMOVE FROM ONE TO THE OTHER. CONSUMER REPORTED FOUND 1 PEN NEEDLE (B)(6) 2023 LAST NIGHT WHEN REMOVED FROM PEN TURNED NEEDLE OFF AFTER USE SLIDED THE COVER OFF PEN NEEDLE, BUT THE COVER ONLY CAME AWAY NEEDLE STAYED ON THE PEN AFTER SHE HAD TURNED IT SEVERAL TIMES. CALLER IS VISUAL IMPAIRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17666749 ↗
• MalfunctionAug 31, 2023Separation Problem; Separation Problem

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G THE OUTER SHIELD DID NOT PROPERLY DETACH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE OUTER COVER TO FALL OFF THE NEEDLE HUB WHEN PLACED INTO HER TRAVEL SHARPS CONTINER. SHE TRANSFERED THE SMALLER CONTAINER TO THE LARGER SHARPS CONTAINTER AND PRICKED HER FINGER A FEW TIMES. NO MEDICAL ATTENTION NEEDED. JUST A STICK UNDER SKIN NO BLOOD. INFORMED CALLER TO LEAVE THE SHARPS IN CONTAINER NEVER REMOVE FROM ONE TO THE OTHER. CONSUMER REPORTED FOUND 1 PEN NEEDLE (B)(6) 2023 LAST NIGHT WHEN REMOVED FROM PEN TURNED NEEDLE OFF AFTER USE SLIDED THE COVER OFF PEN NEEDLE, BUT THE COVER ONLY CAME AWAY NEEDLE STAYED ON THE PEN AFTER SHE HAD TURNED IT SEVERAL TIMES. CALLER IS VISUAL IMPAIRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17666745 ↗
• MalfunctionAug 31, 2023Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G LEAKAGE OCCURRED AND THE SHIELD WAS NOT PROPERLY REMOVED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM PHONE CALL ON (B)(6) 2023 12:38:40: CONSUMER RETURNED REP'S CALL. SHE STATED THAT THE INSULIN IS LEAKING THROUGH THE HUB. CONSUMER IS NEW TO USING PEN NEEDLES. AFTER REVIEWING THE STEPS FOR ATTACHING THE NEEDLES, IT WAS REALIZED THAT THE CONSUMER WAS NOT REMOVING THE INNER SHIELD. DATE OF EVENT IS (B)(6), NOT (B)(6). USING BD (PEN NEEDLE 4MM NANO 32G) THE CUSTOMER NOTICED SEEPING FROM THE NEEDLE (B)(6) 2023 (NO TIME GIVEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17658870 ↗
• MalfunctionAug 29, 2023Failure to Prime; Failure to Prime

  IT WAS REPORTED UNABLE TO PRIME WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647397 ↗
• MalfunctionAug 28, 2023Device Alarm System; No Apparent Adverse Event; Device Alarm System; No Apparent Adverse Event

  IT WAS REPORTED WHILE INFUSING LACTATED RINGERS IV FLUID THE DEVICE PRODUCED AN ERROR, READING "FAULT 282- MOTOR MOTION HINDERED". THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17629130 ↗
• MalfunctionAug 17, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT 7 OF THE BD NANO¿ 2ND GEN PEN NEEDLE HAD NEEDLE CLOGS. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED FINDING DURING INJECTION THE NEEDLE CLOGS. WITH 7 DIFFERENT PEN NEEDLES FROM THIS BOX. INFORMED CALLER OF THE NON PATIENT END PLACEMENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17564150 ↗
• MalfunctionAug 15, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT THE BD NANO¿ ULTRA FINE¿ PEN NEEDLE HAD NOT LOT INFORMATION. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THERE IS NO LOT #, EWO02513 IS WRITTEN WHERE THE LOT # WOULD BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553164 ↗
• MalfunctionAug 2, 2023Missing Information; Missing Information

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G THE LABEL HAD INCORRECT INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT SHE RECEIVED A DEMO BOX OF NANO PEN NEEDLES. SHE STATED THAT THE BOX HAS EWO WRITTEN ON IT AND THE TEAR DROP LABELS ARE PINK AND THERE ARE NO NEEDLES ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446899 ↗