BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Report
- Report Number
- 2243072-2019-02164
- Event Type
- Malfunction
- Date Received
- October 1, 2019
- Date of Event
- September 16, 2019
- Report Date
- October 29, 2019
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- PMA / PMN Number
- K183399
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE CATHETER WAS DEFECTIVE AND DID NOT WORK WITH AN BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER DID NOT WORK. MEDICAL DEVICE BRAND NAME: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC, SANDY, UT 84070. MEDICAL DEVICE CATALOG #: 383539. UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC, SANDY, UT 84070. PMA / 510(K)#: K183399.
H.6. INVESTIGATION SUMMARY: RECEIVED ONE Q-SYTE CLOSED LUER ACCESS DEVICE WITH BLUE DUST CAP INTACT. THERE WAS VISIBLE DAMAGE TO THE TOP DISK OF THE SEPTUM AND THE TOP BODY (POLYCARBONATE). A DHR WAS NOT PERFORMED AS THE LOT NUMBER IS "UNKNOWN" FOR THIS COMPLAINT. VISUAL / MICROSCOPIC EVALUATION: THE DAMAGE TO THE SEPTUM TOP DISK ARE TEARS. THE DAMAGE TO THE TOP BODY (POLYCARBONATE) ARE BREAKS AND DISTORTION. CONCLUSION(S): INDETERMINATE ¿ ALTHOUGH THE DEFECT OF ADAPTER / CONNECTOR DEFECTIVE / DAMAGED, WAS IDENTIFIED AND CONFIRMED, A ROOT CAUSE WAS NOT ESTABLISHED. BASED ON THE EVALUATION CONDUCTED ON THE RETURNED UNIT, WHERE AND HOW THE DAMAGE OCCURRED TO THE Q-SYTE COULD NOT BE ESTABLISHED, AS THE Q-SYTE WAS OUT OF PACKAGING. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. H3 OTHER TEXT : SEE SECTION H.10
THE FOLLOWING INFORMATION HAS BEEN ADDED BASED ON INVESTIGATION OF SAMPLE THAT WAS RECEIVED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE CATHETER WAS DEFECTIVE ON THE COMPONIENT Q-SYTE - ADAPTER AND DID NOT WORK WITH AN BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER DID NOT WORK. IT WAS CLARIFIED THAT THE Q-SYTE LUER ACCESS DEVICE WAS WARPED SO IT WOULD NOT CONNECT TO ANYTHING. D.10. DEVICE AVAILABLE FOR EVAL? YES D.10 RETURNED TO MANUFACTURER ON: 2019-10-07. F.10 DEVICE CODES: 1354. H.1 DEVICE RETURN TO MANUF .?: YES H3 OTHER TEXT : SEE H.10
IT WAS REPORTED THAT THE CATHETER WAS DEFECTIVE AND DID NOT WORK WITH AN BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER DID NOT WORK.
IT WAS REPORTED THAT THE CATHETER WAS DEFECTIVE ON THE COMPONIENT Q-SYTE - ADAPTER AND DID NOT WORK WITH AN BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER DID NOT WORK. IT WAS CLARIFIED THAT THE Q-SYTE LUER ACCESS DEVICE WAS WARPED SO IT WOULD NOT CONNECT TO ANYTHING.
IT WAS REPORTED THAT THE CATHETER WAS DEFECTIVE ON THE COMPONIENT Q-SYTE - ADAPTER AND DID NOT WORK WITH AN BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER DID NOT WORK. IT WAS CLARIFIED THAT THE Q-SYTE LUER ACCESS DEVICE WAS WARPED SO IT WOULD NOT CONNECT TO ANYTHING.
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 AND 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.
IT WAS REPORTED THAT THE CATHETER WAS DEFECTIVE AND DID NOT WORK WITH AN UNSPECIFIED BD NEXIVA 18G. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER DID NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 937227 | BD NEXIVA¿ CLOSED IV CATHETER SYSTEM | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |