NEEDLE 27X1-1/4 RB
Report
- Report Number
- 1911916-2026-00005
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Date of Event
- December 19, 2025
- Report Date
- March 24, 2026
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMI
- UDI-DI
- 30382903051367
- PMA / PMN Number
- K021475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4). FOLLOW UP. THE CUSTOMER REPORTED THAT LIQUID WAS OBSERVED EXTRUDING THROUGH A HOLE IN THE NEEDLE HUB. BECAUSE THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE PROVIDED FOR REVIEW BY THE QUALITY TEAM. THE IMAGES SHOW A NEEDLE ASSEMBLED TO A SYRINGE. ONE IMAGE, TAKEN UNDER MAGNIFICATION, INCLUDES A DARK ARROW INDICATING WHAT APPEARS TO BE A HOLE IN THE NEEDLE HUB. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE PHOTOGRAPHS. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 305136, LOT 2021694, IDENTIFIED NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS WERE IN COMPLIANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND THE PHOTOGRAPHIC EVIDENCE, THE REPORTED SYMPTOM IS CONFIRMED. HOWEVER, IN THE ABSENCE OF THE PHYSICAL SAMPLE, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
(B)(6) FOLLOW UP FOR DEVICE EVALUATION. THE CUSTOMER REPORTED OBSERVING LIQUID EXTRUDING THROUGH A HOLE IN THE NEEDLE HUB. TO SUPPORT THE INVESTIGATION, ONE UNBLISTERED SAMPLE AND TWO PHOTOGRAPHS WERE PROVIDED FOR REVIEW BY THE QUALITY TEAM. A VISUAL INSPECTION OF THE SAMPLE IDENTIFIED A PINHOLE LOCATED APPROXIMATELY 7 32 INCH FROM THE BOTTOM OF THE NEEDLE HUB. THE SAMPLE WAS ASSEMBLED TO A SYRINGE FILLED WITH SALINE SOLUTION AND TESTED, AT WHICH POINT FLUID WAS OBSERVED EXPELLING NOT ONLY THROUGH THE NEEDLE, BUT ALSO THROUGH THE PINHOLE. THE PHOTOGRAPHS DEPICT A NEEDLE ASSEMBLED TO A SYRINGE, WITH ONE MAGNIFIED IMAGE SHOWING A DARK ARROW INDICATING WHAT APPEARS TO BE A HOLE IN THE NEEDLE HUB. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE IMAGES. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT WEAR OF THE STRIPPING BUSHING WITHIN THE MOLDING TOOL COULD CONTRIBUTE TO THIS CONDITION, AND CORRECTIVE ACTION WAS IMPLEMENTED THROUGH INSTALLATION OF A NEW STRIPPING BUSHING. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER: 305136, LOT: 2021694, IDENTIFIED NO QUALITY ISSUES DURING MANUFACTURING THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE DOCUMENTED, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE COMPLETED IN COMPLIANCE WITH APPLICABLE SPECIFICATIONS. AT THE TIME OF THIS REVIEW, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION RESULTS, INCLUDING EVALUATION OF THE PHYSICAL SAMPLE AND PHOTOGRAPHIC EVIDENCE, THE REPORTED SYMPTOM IS CONFIRMED.
IT IS REPORTED, HOLE IN THE NEEDLE HUB. MATERIAL: 305136. BATCH: 2021694. WHILE TESTING A SYRINGE FOR BREAK LOOSE GLIDE FORCE USING A BD NEEDLE, LIQUID WAS SEEN EXTRUDING THROUGH A HOLE IN THE NEEDLE HUB AS WELL AS THE NEEDLE DURING TESTING. ADDITIONAL INFORMATION: THE NEEDLE WAS USED DURING BREAK LOOSE GLIDE FORCE TESTING. THE RESULT OF THAT TEST IS INVALID DUE TO THE DEFECT IN THE NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457735 | NEEDLE 27X1-1/4 RB | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 2021694 | 30382903051367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |