BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Report
- Report Number
- 2243072-2022-00920
- Event Type
- Malfunction
- Date Received
- July 8, 2022
- Date of Event
- June 9, 2022
- Report Date
- August 30, 2022
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 00382903851003
- PMA / PMN Number
- K013621
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE USING A BD Q-SYTE¿ STAND-ALONE DEVICE, THE DEVICE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE Q-SYTE'S WILL NOT OPEN WHEN ACCESSED. D.1. MEDICAL DEVICE BRAND NAME: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; D.3. MEDICAL DEVICE MANUFACTURER: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; D.4. MEDICAL DEVICE CATALOG #: 385100; D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4); G.1. MANUFACTURING LOCATION: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; G.5. PMA / 510(K)#: K013621. H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPH FOR EVALUATION. BD RECEIVED 4 Q-SYTE ASSEMBLIES AND ONE PHOTOGRAPH. A MICROSCOPIC INSPECTION OF THE SEPTUM WAS PERFORMED, AND IT WAS FOUND THAT THE BOTTOM DISKS AND ALL RETURNED UNITS DID NOT HAVE SLITS IN THEM. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. ONE OF THE DEVICES HAD AN INCOMPLETE WELDING LEADING TO SEPARATION OF THE MALE FROM FEMALES LUERS. THE SEPTA ARE SLIT DURING THE MANUFACTURING PROCESS. IF A SEPTUM IS NOT SLIT IT MAY BE A RESULT OF A BROKEN/MISSING BLADE, OR MIXED PRODUCT OF NON-SLIT SEPTUM WITH SLIT SEPTUM. THERE IS A 100% INSPECTION DURING THE LUBE STATION THAT CHECKS FOR THE PRESENCE OF A SLIT. IT IS POSSIBLE THAT A NO SLIT WOULD PASS IF THE STATION ACTUATION FORCE IS SET TOO HIGH. OPERATORS ALSO INSPECT FOR NO SLIT PER THE QUALITY PLAN. DURING MANUFACTURING, THE INCOMPLETE WELDING MAY OCCUR DUE TO IMPROPER SETUP. OPERATORS PERFORMED INSPECTION AT SET UP WELD FOR PART ALIGNMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED UNSPECIFIED BD Q-SYTE¿ STAND-ALONE DEVICE WAS CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I SENT THIS IN BECAUSE HOPE WHEN A CUSTOMER ORDERS NEXIVA OR Q-SYTE STAND ALONES THEY ARE NOT ¿CLOGGED¿ LIKE THESE ARE AND CANNOT USE."
IT WAS REPORTED THAT WHILE USING A BD Q-SYTE¿ STAND-ALONE DEVICE, THE DEVICE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE Q-SYTE'S WILL NOT OPEN WHEN ACCESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1986575 | BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE | INTRAVASCULAR ADMINISTRATION SET | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | UNKNOWN | 00382903851003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |