BD CONNECTA¿ 3-WAY STOPCOCK
Report
- Report Number
- 9610847-2023-00259
- Event Type
- Malfunction
- Date Received
- September 12, 2023
- Date of Event
- August 28, 2023
- Report Date
- November 10, 2023
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FMG
- PMA / PMN Number
- K974083
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1152280 D4: MEDICAL DEVICE EXPIRATION DATE: 21-MAY-2024 H4: DEVICE MANUFACTURE DATE: 18-AUG-2021
OUR QUALITY ENGINEER INSPECTED THE 3 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LOOSE COMPONENT NO LEAK WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTOS. THE DEFECT REPORTED COULD NOT BE SEEN IN THE SAMPLE PHOTOS SUPPLIED. BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED FAILURE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. H3 OTHER TEXT : SEE NARRATIVE BELOW.
IT WAS REPORTED THAT THE BD CONNECTA¿ 3-WAY STOPCOCK HAD A LOOSE CONNECTION DURING USE. THIS OCCURRED WITH 10 STOPCOCKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE NURSE MANAGER REPORTED THAT THE NUTS WERE FOUND TO BE UNTIGHTENED DURING USE."
IT WAS REPORTED THAT THE BD CONNECTA¿ 3-WAY STOPCOCK HAD A LOOSE CONNECTION DURING USE. THIS OCCURRED WITH 10 STOPCOCKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE NURSE MANAGER REPORTED THAT THE NUTS WERE FOUND TO BE UNTIGHTENED DURING USE."
BATCH NUMBER SUPPLIED. THE NURSE MANAGER REPORTED THAT THE NUTS WERE FOUND TO BE UNTIGHTENED DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1231614 | BD CONNECTA¿ 3-WAY STOPCOCK | STOPCOCK | FMG | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 1152280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |