BD EPILOR¿ PLASTIC LOR SYRINGE
Report
- Report Number
- 9610847-2022-00312
- Event Type
- Malfunction
- Date Received
- August 17, 2022
- Date of Event
- July 14, 2022
- Report Date
- May 31, 2023
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- CAZ
- PMA / PMN Number
- K210983
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 14 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF INSERTION DIFFICULT WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT ALL 14 SAMPLES WERE FOUND TO BE WITHIN PROPER MANUFACTURING SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED, AND NO ISSUES WERE FOUND WITH THE SAMPLES. BD CANNOT DETERMINE THE CAUSE OF THE FAILURE SINCE THE DEFECT WAS NOT CONFIRMED. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH WAS IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H.10.
TWO LOTS WERE INITIALLY REPORTED FOR THIS COMPLAINT, HOWEVER, ONLY 1 WAS REPORTED. PLEASE SEE THE CORRECT INFORMATION BELOW FOR THIS COMPLAINT: D4: MEDICAL DEVICE LOT #: 1033079. D4: MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026. H4: DEVICE MANUFACTURE DATE: 02-FEB-2021. D4: MEDICAL DEVICE LOT #: 1006844. D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025. H4: DEVICE MANUFACTURE DATE: 06-JAN-2021. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 14 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF INSERTION DIFFICULT WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT ALL 14 SAMPLES WERE FOUND TO BE WITHIN PROPER MANUFACTURING SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED, AND NO ISSUES WERE FOUND WITH THE SAMPLES. BD CANNOT DETERMINE THE CAUSE OF THE FAILURE SINCE THE DEFECT WAS NOT CONFIRMED. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND BATCH 1033079 AND 1006844 WERE IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.
IT WAS REPORTED THAT THERE WAS NO RESISTANCE WITH THE BD EPILOR¿ PLASTIC LOR SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS NO RESISTANCE MAKING IT DIFFICULT FOR DOCTOR TO FIND THE EPIDURAL SPACE.
IT WAS REPORTED THAT THERE WAS NO RESISTANCE WITH THE BD EPILOR¿ PLASTIC LOR SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS NO RESISTANCE MAKING IT DIFFICULT FOR DOCTOR TO FIND THE EPIDURAL SPACE.
IT WAS REPORTED THAT THERE WAS NO RESISTANCE WITH THE BD EPILOR¿ PLASTIC LOR SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS NO RESISTANCE MAKING IT DIFFICULT FOR DOCTOR TO FIND THE EPIDURAL SPACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2297225 | BD EPILOR¿ PLASTIC LOR SYRINGE | ANESTHESIA CONDUCTION KIT | CAZ | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |