BD¿ NEEDLE 2 IN. SINGLE USE, STERILE, 21 G
Report
- Report Number
- 1911916-2022-00771
- Event Type
- Malfunction
- Date Received
- December 22, 2022
- Date of Event
- December 2, 2022
- Report Date
- January 12, 2023
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMI
- PMA / PMN Number
- K021475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THERE IS A WHITE SUBSTANCE ON THE NEEDLE. TO AID IN THE INVESTIGATION, SEVEN PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. TWO PHOTOS SHOW A CERTIFICATE OF COMPLIANCE. THREE PHOTOS SHOW A NEEDLE ASSEMBLY WITH NO DEFECTS OR IMPERFECTIONS. THE OTHER TWO PHOTOS SHOW A NEEDLE ASSEMBLY WITH AN EPOXY DRIP OVER ON THE NEEDLE HUB. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS. DURING MANUFACTURING, THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR, THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE EPOXY TO FIX IT. AFTER, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE WHITE EPOXY DRIP OVER ON THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305129, LOT NUMBER 0202355. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. H3 OTHER TEXT : SEE H10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 06-JAN-2023. H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT THERE IS A WHITE SUBSTANCE ON THE NEEDLE. TO AID IN THE INVESTIGATION, FORTY-FOUR SAMPLES AND SEVEN PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. FORTY-TWO SAMPLES CAME IN SEALED PACKAGING BLISTERS AND TWO CAME WITH NO PACKAGING. EACH SAMPLE HAS THE PLASTIC SHIELD. A VISUAL INSPECTION WAS PERFORMED. THREE SAMPLES HAVE AN EPOXY DRIP OVER ON THE NEEDLE HUB. IN THE PHOTOS PROVIDED, TWO PHOTOS SHOW A CERTIFICATE OF COMPLIANCE. THREE PHOTOS SHOW A NEEDLE ASSEMBLY WITH NO DEFECTS OR IMPERFECTIONS. THE OTHER TWO PHOTOS SHOW A NEEDLE ASSEMBLY WITH AN EPOXY DRIP OVER ON THE NEEDLE HUB. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS. DURING MANUFACTURING, THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR, THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE EPOXY TO FIX IT. AFTER, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE WHITE EPOXY DRIP OVER ON THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305129, LOT NUMBER 0202355. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED WHILE USING BD¿ NEEDLE 2 IN. SINGLE USE, STERILE, 21 G FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE APPEARS TO BE A WHITE SUBSTANCE IN THE BARREL OF SOME OF THESE NEEDLES THAT IS NOT NORMALLY PRESENT.
IT WAS REPORTED WHILE USING BD¿ NEEDLE 2 IN. SINGLE USE, STERILE, 21 G FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE APPEARS TO BE A WHITE SUBSTANCE IN THE BARREL OF SOME OF THESE NEEDLES THAT IS NOT NORMALLY PRESENT.
IT WAS REPORTED WHILE USING BD¿ NEEDLE 2 IN. SINGLE USE, STERILE, 21 G FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE APPEARS TO BE A WHITE SUBSTANCE IN THE BARREL OF SOME OF THESE NEEDLES THAT IS NOT NORMALLY PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2139402 | BD¿ NEEDLE 2 IN. SINGLE USE, STERILE, 21 G | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 305129 | 0202355 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |