BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Report
- Report Number
- 9610847-2022-00004
- Event Type
- Malfunction
- Date Received
- January 18, 2022
- Date of Event
- December 10, 2021
- Report Date
- January 21, 2022
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FOZ
- UDI-DI
- 30382903833369
- PMA / PMN Number
- K013800
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: SINCE NO PHOTOS OR SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM BROKE FROM THE HUB WHILE INJECTING ANESTHETIC SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "PATIENT WAS WITH ENDOMETRIAL POLYPS SHOULD BE ADMITTED TO HOSPITAL FOR SURGERY RESECTION, PREOPERATIVE TO INDWELLING VENOUS INDWELLING NEEDLE, GIVE INJECTION ANESTHETIC SOLUTION AND INTRAOPERATIVE MEDICATION USE, WHEN THE BACK NEEDLE, TRANSPARENT PIPELINE RUPTURE, THEN IMMEDIATELY WIPE OUT FRACTURE VENOUS INDWELLING NEEDLE, RESET THE NEEDLE, GIVING PATIENTS PATIENTS OPINION IS VERY BIG, THE HEAD NURSE CONCILIATION, THE PATIENT HAS NO OPINION."
IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM BROKE FROM THE HUB WHILE INJECTING ANESTHETIC SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "PATIENT WAS WITH ENDOMETRIAL POLYPS SHOULD BE ADMITTED TO HOSPITAL FOR SURGERY RESECTION, PREOPERATIVE TO INDWELLING VENOUS INDWELLING NEEDLE, GIVE INJECTION ANESTHETIC SOLUTION AND INTRAOPERATIVE MEDICATION USE, WHEN THE BACK NEEDLE, TRANSPARENT PIPELINE RUPTURE, THEN IMMEDIATELY WIPE OUT FRACTURE VENOUS INDWELLING NEEDLE, RESET THE NEEDLE, GIVING PATIENTS PATIENTS OPINION IS VERY BIG, THE HEAD NURSE CONCILIATION, THE PATIENT HAS NO OPINION."
IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM BROKE FROM THE HUB WHILE INJECTING ANESTHETIC SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "PATIENT WAS WITH ENDOMETRIAL POLYPS SHOULD BE ADMITTED TO HOSPITAL FOR SURGERY RESECTION, PREOPERATIVE TO INDWELLING VENOUS INDWELLING NEEDLE, GIVE INJECTION ANESTHETIC SOLUTION AND INTRAOPERATIVE MEDICATION USE, WHEN THE BACK NEEDLE, TRANSPARENT PIPELINE RUPTURE, THEN IMMEDIATELY WIPE OUT FRACTURE VENOUS INDWELLING NEEDLE, RESET THE NEEDLE, GIVING PATIENTS PATIENTS OPINION IS VERY BIG, THE HEAD NURSE CONCILIATION, THE PATIENT HAS NO OPINION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1052398 | BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM | INTRAVASCULAR CATHETER | FOZ | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 383336 | 0351262 | 30382903833369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |