BD Q-SYTE¿ TRI-EXTENSION SET
Report
- Report Number
- 9610847-2023-00086
- Event Type
- Malfunction
- Date Received
- April 13, 2023
- Date of Event
- March 27, 2023
- Report Date
- May 19, 2023
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 00382903851584
- PMA / PMN Number
- K142527
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 17-APR-2023. H6: INVESTIGATION SUMMARY IT WAS REPORTED THE CUSTOMER WAS UNABLE TO INSERT THE SYRINGES IN THE SPLIT SEPTUM WHICH RESULTED IN THE INABILITY TO GIVE MEDICATION AND LEAKAGE. TO AID IN THE INVESTIGATION, THREE Q-SYTE ASSEMBLIES FROM LOT 2033442 WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE UNITS HAVE NOT BEEN USED BUT ARE NOT SEALED IN THE PACKAGING. A GOLF PIN WAS USED TO IDENTIFY THE ACCESS THROUGH THE UNITS. DURING THE INSERTION OF THE PIN, IT WAS DETERMINED THAT THE DISKS ON THE UNITS DID NOT HAVE SLITS ON THEM. THE SEPTA ARE SLIT DURING THE MANUFACTURING PROCESS. IF A SEPTUM IS NOT SLIT, IT MAY BE A RESULT OF A BROKEN BLADE, MISSING BLADE, OR MIXED PRODUCT OF NON-SLIT SEPTUM WITH A SLIT SEPTUM. THERE IS A 100% INSPECTION DURING THE LUBE STATION THAT CHECKS FOR THE PRESENCE OF A SLIT. IT COULD BE POSSIBLE THAT A NO SLIT WOULD PASS IF THE STATION ACTUATION FORCE WAS SET TOO HIGH. OPERATORS ALSO INSPECT FOR NO SLIT PER THE QUALITY PLAN. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 385158, LOT 2033442. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THERE WERE NO NONCONFORMANCES, CAPAS OR ABNORMAL CONDITIONS NOTED AT THE TIME OF PRODUCTION. AT THE TIME OF THE DHR REVIEW, THERE WERE NO CHANGES TO THE PROCESS AND/OR EQUIPMENT THAT WOULD HAVE AFFECTED THE MANUFACTURING OF THE DEVICE. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF UNITS USED IN THE MANUFACTURING OF THIS BATCH AND NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THE COMPLAINT. BASED ON THE INVESTIGATION, THE REPORT THAT THE Q-SYTE CONNECTOR COULD NOT BE ACCESSED WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. THE SEPTUM ON THE Q-SYTE CONNECTORS HAD NOT BEEN SLIT, WHICH PREVENTED INFUSION OF FLUID THROUGH THE CONNECTOR AND LIKELY CONTRIBUTED TO THE REPORTED DRUG SPILL.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT MEDICATION LEAKED FROM THE TOP OF THE BD Q-SYTE¿ TRI-EXTENSION SET SEPTUM. THIS OCCURRED WITH 5 SETS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT ABLE TO INSERT THE SYRINGES IN THE SPLIT SEPTUM. SO THAT UNABLE TO GIVE MEDICATION AND ALSO DRUG SPILL IS HAPPENING."
IT WAS REPORTED THAT MEDICATION LEAKED FROM THE TOP OF THE BD Q-SYTE¿ TRI-EXTENSION SET SEPTUM. THIS OCCURRED WITH 5 SETS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT ABLE TO INSERT THE SYRINGES IN THE SPLIT SEPTUM. SO THAT UNABLE TO GIVE MEDICATION AND ALSO DRUG SPILL IS HAPPENING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1095709 | BD Q-SYTE¿ TRI-EXTENSION SET | INTRAVASCULAR ADMINISTRATION SET | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 2033442 | 00382903851584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |