BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN
Report
- Report Number
- 9610847-2022-00072
- Event Type
- Malfunction
- Date Received
- February 22, 2022
- Date of Event
- February 9, 2022
- Report Date
- April 25, 2022
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FOZ
- UDI-DI
- 30382903833239
- PMA / PMN Number
- K013800
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1041993. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, ALTHOUGH SEVERAL SAMPLES WERE SUBMITTED FOR EVALUATION, ALL SAMPLES WERE SEALED AND DID NOT DISPLAY ANY OBSERVABLE NON-CONFORMANCES. UNFORTUNATELY DUE TO CURRENT CUSTOMS LAW IN CHINA, THE RETURNED SAMPLES COULD NOT BE SUBMITTED TO THE FACILITY OF MANUFACTURE FOR FUNCTIONAL TESTING. INSTEAD ARRANGEMENTS WERE MADE TO HAVE PHOTOGRAPHS OF THE AFFECTED SAMPLES SUBMITTED FOR VISUAL ANALYSIS. ALL RETURNED SAMPLES WERE SEALED AND DID NOT DISPLAY OBSERVABLE NON-CONFORMANCES. IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. BASED ON THE AVAILABLE OBSERVATIONS AND REPRESENTATIVE TEST RESULTS OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.
IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN THE HUB WAS NOT CONNECTING SECURELY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 383323 BATCH#: 1041993. IT WAS REPORTED DEFECTIVE HUB, "THE CONNECTED CLAVE ( HUB) ARE LOOSE AND FALL OFF."
IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN THE HUB WAS NOT CONNECTING SECURELY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 383323 BATCH#: 1041993. IT WAS REPORTED DEFECTIVE HUB, "THE CONNECTED CLAVE ( HUB) ARE LOOSE AND FALL OFF."
IT WAS REPORTED WHILE USING BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN THE HUB WAS NOT CONNECTING SECURELY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 383323 BATCH#: 1041993- IT WAS REPORTED DEFECTIVE HUB, "THE CONNECTED CLAVE ( HUB) ARE LOOSE AND FALL OFF."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 686232 | BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN | INTRAVASCULAR CATHETER | FOZ | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 383323 | 1041993 | 30382903833239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |