BD SafetyGlide 305921Recalls & reported problems
Becton, Dickinson And Company · NEEDLE SFTYGLD 27X5/8 RB · Class 2
All models of BD SafetyGlide (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00382903059218), received between Oct 26, 2017 and Feb 21, 2025 — classified as 3 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
4 other recalls cover devices cleared under the same FDA submission (K951254); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Leak/Splash3
- Device Contamination with Chemical or Other Material2
- Retraction Problem2
- Defective Component1
- Detachment of Device or Device Component1
- Device Markings/Labelling Problem1
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient3
- Foreign Body In Patient2
- No Patient Involvement2
- Needle Stick/Puncture1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21439129 ↗MalfunctionFeb 5, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21314666 ↗MalfunctionSep 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20186173 ↗InjuryMay 30, 2024Break; Break
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Needle Stick/Puncture
MAUDE report 19427221 ↗MalfunctionJul 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT NEEDLE PULLED OUT OF HUB WHILE USING BD SAFETYGLIDE¿ NEEDLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON ENGAGING THE SAFETY NEEDLE GUARD TO COVER THE USED NEEDLE, THE NEEDLE DETACHED FROM THE SECUREMENT BASE. NO INJURY TO STAFF OR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15136319 ↗InjuryAug 17, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE PATIENT RECEIVED UNSPECIFIED MEDICAL INTERVENTION WITH THE FINAL OUTCOME BEING UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE NEED TO BE LOGGED IN FOR TRENDING AND VIGILANCE REPORTING ONLY. PULLED FROM "HEALTH (B)(6) MEDICAL DEVICES ONLINE DATABASES. UNEXPECTED MEDICAL INTERVENTION, NO CLINICAL SIGNS SYMPTOMS OR CONDITIONS, BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12330899 ↗MalfunctionJun 1, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 5 BD SAFETYGLIDE" NEEDLES LEAKED FROM THE CONNECTION TO THE PHASEAL OPTIMA CONNECTOR. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WITH THIS NEEDLE WE HAVE BEEN NOTICING LATELY AN INCREASE IN LEAKING AROUND THE NEEDLE IN ONCOLOGY, WHERE IT CONNECTS TO THE PHASEAL OPTIMA CONNECTOR. I'M THINKING IT'S THE NEEDLE AND NOT THE CONNECTOR ITSELF AND AM WORKING WITH THE COMPANY REGARDING THE NEEDLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11917985 ↗InjuryDec 30, 2020Break; Break
IT WAS REPORTED THAT THE NEEDLE SFTYGLD 27X5/8 RB BROKE OFF AND THE PATIENT HAD TO RECEIVE UNEXPECTED MEDICAL INTERVENTION AS A RESULT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "F23 - UNEXPECTED MEDICAL INTERVENTION. (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 11095595 ↗MalfunctionJul 9, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT PRIOR TO USE THE LABEL IS DISCOVERED MISSING FROM BACK OF 10 PACKAGE WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INDIVIDUAL ITEMS ARE SUPPOSED TO HAVE LABEL INFO ON THE BACK PLASTIC WRAP AND WHEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 10253521 ↗MalfunctionJun 29, 2020Retraction Problem; Retraction Problem
IT WAS REPORTED THAT NEEDLE SFTYGLD 27X5/8 RB SAFETY MECHANISM WAS BROKEN. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305921 BATCH NO: 0002401. IT WAS REPORTED THAT: RN REMOVED SYRINGE FROM PACKAGE, REVEALED NO SAFETY SHIELD ON/FOR NEEDLE. EVENT DESCRIPTION PER EMAIL STATES: RN ADMINISTERED SUBCUTANEOUS INJECTION AT PATIENT BEDSIDE. RN WENT TO DO ACTIVATE THE SAFETY NEEDLE DEVICE AND WAS UNABLE TO DO SO AS PART OF THE SAFETY DEVICE WAS MISSING/BROKEN. RN SEARCHED PATIENTS BEDDING AND FLOOR FOR MISSING PIECE. RN DID NOT HEAR/FEEL ANYTHING BREAK OR FALL TO FLOOR. RN STATED "I THINK IT'S JUST MISSING A PIECE". RN ALSO STATED SHE "GAVE THE INJECTION BEFORE I NOTICED A PIECE WAS MISSING." SAFETY CLOSURE DEVICE BROKEN AND UNABLE TO ACTIVATE THE SAFETY MECHANISM.
Patient problems: No Patient Involvement
MAUDE report 10209906 ↗MalfunctionMar 17, 2020Retraction Problem
NURSE WHEN TO GIVE A VACCINATION TO A NEW BORN. SHE APPLIED A NEEDLE TO THE PREFILLED SYRINGE AND AFTER SHE GAVE THE INJECTION TO THE BABY SHE ATTEMPTED TO DEPLOY THE SAFETY DEVICE AND THE SAFETY DEVICE BROKE OFF. MANUFACTURER RESPONSE FOR SAFETY NEEDLE 27 G X 5/8, BD SAFETYGLIDE (PER SITE REPORTER). THIS WAS DONE BY OUR SUPPLY CHAIN CORPORATE OFFICE. I'M NOT SURE WHAT THE RESPONSE WAS.
Patient problems: Foreign Body In Patient
MAUDE report 9841248 ↗MalfunctionFeb 17, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT NEEDLE SFTYGLD 27X5/8 RB SAFETY MECHANISM BROKE. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305921 BATCH NO: 9170943 IT WAS REPORTED THAT WHEN TRYING TO ACTIVATE THE SAFETY FUNCTION, THE PLASTIC SAFETY BROKE OFF LEAVING THE NEEDLE EXPOSED. EVENT DESCRIPTION PER EMAIL STATES: I WANTED TO REPORT A BROKEN SAFETY ON A NEEDLE THAT WAS BROKEN AND POSED A SAFETY RISK TO ONE OF OUR CAREGIVERS DURING AN INJECTION AT OUR HOSPITAL ON 1/24. THIS WAS ESCALATED TO OUR SENIOR LEADERSHIP. A NURSE WAS GIVING A HEP B VACCINE TODAY TO A BABY AND AFTER GIVING THE INJECTION AND TRYING TO ACTIVATE THE SAFETY FUNCTION THE PLASTIC SAFETY BROKE OFF LEAVING THE NEEDLE EXPOSED. THE ITEM NUMBER IS A BG SAFETYGLIDE NEEDLE 27 G X 5/8 IN. I TOOK PICTURES OF THE PACKAGING AND OF THE NEEDLE WITH THE PLASTIC SAFETY BROKEN OFF. IT SHOULD HAVE REMAINED INTACT TO COVER THE NEEDLE TO PREVENT NEEDLE STICKS. WE PUT THE NEEDLE IN THE SHARPS SINCE IT HAD BEEN INJECTED INTO AN INFANT JUST A FEW MINUTES BEFORE. THIS DID NOT RESULT IN A NEEDLE STICK IN AN EMPLOYEE BUT HAD THE POTENTIAL TO BE A SAFETY RISK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9717817 ↗MalfunctionDec 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
MATERIAL NO. 305921, BATCH NO. UNKNOWN. IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE HAD AN ISSUE WITH FOREIGN MATTER. THERE IS A BLACK SUBSTANCE IN THE BARREL OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED VOICEMAIL FROM PHARMACY MANAGER STATING, HE IS NOTICING "BLACK SUBSTANCE" IN THE BARREL OF SYRINGE. STATED, HE DISCARDED STATED, ONLY 1 SYRINGE AFFECTED ITEM: 305921.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9437682 ↗MalfunctionDec 3, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING INJECTION LEAKAGE OCCURRED FROM THE HUB WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN GIVING A B12 INJECTION THE NEEDLE LEAKED FROM THE LOCATION OF WHERE THE SAFETY DEVICE ATTACHES TO THE HUB. WITHDREW NEEDLE FROM PT AND OBTAINED ANOTHER NEEDLE TO FINISH THE INJECTION WITHOUT DIFFICULTY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9403619 ↗MalfunctionOct 26, 2017Device Operates Differently Than Expected
IT WAS REPORTED BY A CLINICIAN THAT THE SAFETY SHEATH ON A 27G X 5/8 IN BD SAFETYGLIDE" NEEDLE FAILED TO ENGAGE BENDING THE NEEDLE AFTER USE. THERE WAS NO REPORT OF MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6980218 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K951254. One submission often covers many models, so check the product and lot details in each record.
- Z-2889-2020 · Jul 28, 2020 · TerminatedBD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
- Z-0315-2018 · Jul 5, 2017 · TerminatedSafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
- Z-3116-2017 · Jun 13, 2017 · TerminatedBD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from
- Z-2748-2017 · Sep 16, 2016 · TerminatedBD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below th
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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