BD PRECISIONGLIDE¿ NEEDLES
Report
- Report Number
- 2020394-2023-00383
- Event Type
- Injury
- Date Received
- May 31, 2023
- Date of Event
- May 4, 2023
- Report Date
- August 15, 2023
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMI
- UDI-DI
- 30382903051275
- PMA / PMN Number
- K021475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
CORRECTION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE WITH THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE ALLEGEDLY BROKE OFF IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY. D1: MEDICAL DEVICE BRAND NAME: BD PRECISIONGLIDE¿ NEEDLES. D1: MEDICAL DEVICE TYPE: FMI. D2: MEDICAL DEVICE MANUFACTURER: BD MEDICAL (BD WEST) MEDICAL SURGICAL. D4: UDI #: (B)(4). D4: MEDICAL DEVICE CATALOG #: 305127. D4: MEDICAL DEVICE LOT #: 2228369. D4: MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2027. H4: DEVICE MANUFACTURE DATE: 16-AUG-2022. G2: MANUFACTURING LOCATION: BD MEDICAL (BD WEST) MEDICAL SURGICAL. G.5. PMA / 510(K)#: K021475. H5: IMDRF ANNEX E GRID: E2008, E2311, E2119. H5: IMDRF ANNEX F GRID: F22, F12.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 14AUG2023. H6: INVESTIGATION SUMMARY: T WAS REPORTED A NEEDLE BROKE OFF INSIDE A PATIENT DURING A BREAST BIOPSY. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER, OR PLASTIC SHIELD, WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM A VISUAL INSPECTION WAS PERFORMED AND THE NEEDLE HUB IS MISSING THE TOP PART OF THE NEEDLE. THE NEEDLE BROKE AT THE TOP OF THE WHITE EPOXY. THE BOTTOM PART IS INSIDE THE NEEDLE HUB ABOUT 3/8" NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305127, LOT 2228369. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT HAVING THE ADDITIONAL PART OF THE NEEDLE, IT IS NOT POSSIBLE TO PROVIDE A PROBABLE ROOT CAUSE.
H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 : DEVICE PENDING RETURN.
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE WITH THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE ALLEGEDLY BROKE OFF IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE WITH THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE ALLEGEDLY BROKE OFF IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE OFF IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1018147 | BD PRECISIONGLIDE¿ NEEDLES | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 2228369 | 30382903051275 | |
| 960964 | BD PRECISIONGLIDE¿ NEEDLES | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 2228369 | 30382903051275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |