FDA Adverse Event
Malfunction
Summary report: N
BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE
MDR report key: 7124326
·
Received December 18, 2017
Report
- Report Number
- 1911916-2017-00371
- Event Type
- Malfunction
- Date Received
- December 18, 2017
- Date of Event
- August 1, 2017
- Report Date
- March 7, 2018
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- MEG
- UDI-DI
- 30382903053118
- PMA / PMN Number
- K011103
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION RESULTS: NO PHOTOS OR SAMPLES WERE RECEIVED IN THE COLUMBUS PLANT FOR EVALUATION THEREFORE FAILURE MODE COULD NOT BE VERIFIED AND ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW WAS COMPLETED. 305311-6263912 CONVERT TO BATCH 8000595/ 6231918 - WAS PRODUCED ON 8/31/16 WITH ZERO DEFECTS FOUND. NO SAMPLE GIVEN TO INVESTIGATE OR CONFIRM. NO ROOT CAUSE IDENTIFIED WITHOUT SAMPLE.
Additional Manufacturer Narrative · 1
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING USE, A BD INTEGRA¿ SYRINGE RETRACTING NEEDLE LEAKED OUT MEDICATION ON THE PATIENT¿S ARM. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 906755 | BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE | PISTON SYRINGE | MEG | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 6263912 | 30382903053118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |