FDA Adverse Event
Malfunction
Summary report: N
10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
MDR report key: 8903092
·
Received August 16, 2019
Report
- Report Number
- 1911916-2019-00827
- Event Type
- Malfunction
- Date Received
- August 16, 2019
- Date of Event
- June 7, 2019
- Report Date
- August 16, 2019
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMF
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION SUMMARY: NO SAMPLE WAS RECEIVED. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR THE LOT# 8100542 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 8100542 DURING THE PRODUCTION RUN. ROOT CAUSE DESCRIPTION: ROOT CAUSE CAN¿T BE CONFIRMED. RATIONALE: NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER ROD BROKE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT 9 O'CLOCK ON (B)(6) 2019, THE RESPONSIBLE NURSE FOUND THAT 1EA FLUSH PLUNGER ROD BROKEN WHEN THE PATIENT WAS INFUSED, AND IMMEDIATELY REPLACED WITH A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 696883 | 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE | SYRINGE | FMF | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 8100542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |