BD Q-SYTE LUER ACCESS SPLIT SEPTUM
Report
- Report Number
- 9610847-2022-00067
- Event Type
- Malfunction
- Date Received
- February 17, 2022
- Date of Event
- February 4, 2022
- Report Date
- March 14, 2022
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 30382903851004
- PMA / PMN Number
- K013621
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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.
A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-22. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED Q-SYTE DEVICE. IN ADDITION, THREE PHOTOGRAPHS WERE SUBMITTED. BASED ON YOUR REPORT, THE SEPTUM HAS MOST LIKELY SEPARATED FROM THE TOP BODY. THROUGH OUR INVESTIGATION, THE TOP BODY WAS PULLED UP BY THE EDGE AND IT WAS IDENTIFIED THAT SEPARATION OF THE TOP DISK AND TOP BODY DID OCCUR. THE REPORTED ISSUE WAS CONFIRMED. THE TOP DISK MAY SEPARATE DUE TO THE MANUFACTURING DEFECTS OF MISSING OR INSUFFICIENT (PARTIAL) ADHESIVE OR MISALIGNMENT OF EXCURSIVE PROBE. DURING APPLICATION TOP DISK SEPARATION MAY OCCUR DUE TO OVER ACTUATING, EXCESSIVE FORCE, ANGLED INSERTION, CONNECTION WITH A NON ISO LUER, AND USE OF NEEDLE OR BLUNT CANNULA. THE UNIT WAS MICROSCOPICALLY INSPECTED FOR ADHESIVE RESIDUE. RESIDUE WAS FOUND TO BE SPREAD-OUT ON THE RIM WITH NO GAPS, INDICATING PROPER ADHESION OF THE SEPTUM. NO OTHER VISIBLE DAMAGE WAS OBSERVED TO THE Q-SYTE UNIT. MISSING OR INSUFFICIENT ADHESIVE WERE REMOVED AS POTENTIAL ROOT CAUSES. DAMAGE DURING MANUFACTURING AND APPLICATION IS EQUALLY POSSIBLE AND WOULD APPEAR THE SAME. THEREFORE, A POTENTIAL ROOT CAUSE CANNOT BE ESTABLISHED WITH CERTAINTY. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED WHILE USING BD Q-SYTE LUER ACCESS SPLIT SEPTUM A SEPTUM CAME UNDONE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S REPORT IS THAT THE SEPTUM OF Q-SYTE WAS SEPARATED DURING USE.
IT WAS REPORTED WHILE USING BD Q-SYTE LUER ACCESS SPLIT SEPTUM A SEPTUM CAME UNDONE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S REPORT IS THAT THE SEPTUM OF Q-SYTE WAS SEPARATED DURING USE.
IT WAS REPORTED WHILE USING BD Q-SYTE LUER ACCESS SPLIT SEPTUM A SEPTUM CAME UNDONE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S REPORT IS THAT THE SEPTUM OF Q-SYTE WAS SEPARATED DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 862018 | BD Q-SYTE LUER ACCESS SPLIT SEPTUM | INTRAVASCULAR ADMINISTRATION SET | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 385100 | 1140006 | 30382903851004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |