SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER
Report
- Report Number
- 9610847-2019-00263
- Event Type
- Malfunction
- Date Received
- April 2, 2019
- Date of Event
- March 4, 2019
- Report Date
- May 30, 2019
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FOZ
- UDI-DI
- 30382903833130
- PMA / PMN Number
- K013800
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTED INFORMATION. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A BD¿ SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER HAD A SECOND SHEALTH/CANNULA OVER THE INTRODUCER NEEDLE, RESULTED IN DISCOMFORT TO THE PATIENT DURING PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ SAF T INTIMA APPEARED TO HAVE A SECOND SHEALTH/CANNULA OVER THE INTRODUCER NEEDLE CAUSING DISCOMFORT TO THE PATIENT DURING THE PROCEDURE. ¿ D.1. MEDICAL DEVICE BRAND NAME: SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE CATALOG # 383312. D.4. MEDICAL DEVICE LOT # 8115943. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. G.5. PMA / 510(K)#: K013800. H.4. DEVICE MANUFACTURE DATE: 2018-05-10. D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 2019-04-02.
H.6. INVESTIGATION: BD WAS ABLE TO VERIFY THE REPORTED ISSUE OF CATHETER DEFECT. BOTH SAMPLES ONLY SHOWED CATHETER OVER BEVEL, ONE OF THEM WAS RECEIVED WITH THE SEMI ACTIVATED SAFETY DEVICE. WE SUSPECTED THAT DURING THE HANDLING THE NEEDLE WAS RETRACTED CAUSING THE REPORTED DEFECT. ALSO THE SAMPLES WERE TESTED FOR LEAK AND NO LEAK WAS FOUND. UNFORTUNATELY, WE COULD NOT DETERMINE EXACT ROOT CAUSE DUE TO THE SAMPLES WERE RECEIVED WITH THE PACKAGE OPENED. DHR WAS REVIEWED WITH THE INTENTION OF FINDING ANY PROBLEM DURING ASSEMBLY OF THE PRODUCT THAT COULD BE RELATED WITH THE REPORTED FAILURE MODES; HOWEVER, NO PROBLEMS WERE FOUND.
IT WAS REPORTED THAT A BD¿ SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER HAD A SECOND SHEALTH/CANNULA OVER THE INTRODUCER NEEDLE, RESULTED IN DISCOMFORT TO THE PATIENT DURING PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ SAF T INTIMA APPEARED TO HAVE A SECOND SHEALTH/CANNULA OVER THE INTRODUCER NEEDLE CAUSING DISCOMFORT TO THE PATIENT DURING THE PROCEDURE. ¿
IT WAS REPORTED THAT A BD¿ SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER HAD A SECOND SHEALTH/CANNULA OVER THE INTRODUCER NEEDLE, RESULTED IN DISCOMFORT TO THE PATIENT DURING PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ SAF T INTIMA APPEARED TO HAVE A SECOND SHEALTH/CANNULA OVER THE INTRODUCER NEEDLE CAUSING DISCOMFORT TO THE PATIENT DURING THE PROCEDURE. "
(B)(6). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 A BD¿ SAF-T-INTIMA IV CATHETER SAFETY SYSTEM HAD A SECOND SHEALTH/CANNULA OVER THE INTRODUCER NEEDLE, RESULTED IN DISCOMFORT TO THE PATIENT DURING PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿SAF T INTIMA APPEARED TO HAVE A SECOND SHEALTH/CANNULA OVER THE INTRODUCER NEEDLE CAUSING DISCOMFORT TO THE PATIENT DURING THE PROCEDURE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265226 | SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER | INTERVASCULAR CATHETER | FOZ | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 8115943 | 30382903833130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |