BD LUER-LOK¿ TIP SYRINGE
Report
- Report Number
- 1911916-2021-01236
- Event Type
- Malfunction
- Date Received
- December 8, 2021
- Date of Event
- November 10, 2021
- Report Date
- November 30, 2021
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMF
- UDI-DI
- 30382903096535
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THE SCALE MARKINGS ARE TWISTED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A PLASTIC BAG AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SCALE MARKING IS SKEWED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS A SYRINGE WITH THE SCALE MARKING SKEWED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE BARREL PRINTING PROCESS INDUCING THE SYMPTOM REPORTED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 1180064. 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 PRINTING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCTS WAS GOOD. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THE SCALE MARKINGS ARE TWISTED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A PLASTIC BAG AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SCALE MARKING IS SKEWED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS A SYRINGE WITH THE SCALE MARKING SKEWED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE BARREL PRINTING PROCESS INDUCING THE SYMPTOM REPORTED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 1180064. 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 PRINTING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCTS WAS GOOD. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE HAD MISALIGNED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS ANOTHER LOT NUMBER WITH AN ISSUE: 1180064 ¿ MARKINGS ARE TWISTED AROUND THE BARREL OF THE SYRINGE."
IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE HAD MISALIGNED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HERE IS ANOTHER LOT NUMBER WITH AN ISSUE: 1180064 ¿ MARKINGS ARE TWISTED AROUND THE BARREL OF THE SYRINGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1856797 | BD LUER-LOK¿ TIP SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 309653 | 1180064 | 30382903096535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |