BD IAG BC PRO GLOBAL
Report
- Report Number
- 1710034-2024-01381
- Event Type
- Malfunction
- Date Received
- November 21, 2024
- Date of Event
- October 25, 2024
- Report Date
- July 14, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903810444
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
ADDITIONAL INFORMATION ADDED IN SECTION B INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381044 AND LOT NUMBER 4152470. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.
CORRECTION: E/F CODES UPDATED.
THE COMPLAINT OF DIFFICULT NEEDLE RETRACTION COULD NOT BE CONFIRMED; HOWEVER, THE REPORTED BLOOD SPLATTER WAS CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. ONE SHIELDED NEEDLE FROM AN 18G INSYTE AUTOGUARD BLOOD CONTROL DEVICE WAS RETURNED FOR INVESTIGATION. WHAT APPEARED TO BE DRY BLOOD RESIDUE WAS OBSERVED WITHIN THE GRIP AND BARREL OF THE SAFETY SHIELD, WHICH SUPPORTS THE COMPLAINTS DESCRIPTION OF BLOOD SPLATTER. THIS TYPE OF EVENT CAN OCCUR IF THE NEEDLE GETS CAUGHT ON THE BLOOD CONTROL VALVE, WHICH CAN HOLD THE VALVE OPEN AND ALLOW BLOOD TO LEAK THROUGH THE VALVE; HOWEVER, SINCE THE IV CATHETER WAS NOT RETURNED FOR INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO RELATED ISSUES WITH THE MANUFACTURING PROCESS. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL NEEDLE RETRACTED SLOWLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: INCIDENT INFORMATION: DATE OF OCCURRENCE: (B)(6)2024 INCIDENT. DESCRIPTION: THE RETRACTION SYSTEM DID NOT WORK ON 2 CATHETERS AND WORKED WITH DIFFICULTY ON A 3RD CATHETER (WITH BLOOD SPLATTER) FOR REFERENCE: (B)(6), LOT: 4152470. WE KEPT THE 3RD CATHETER (BUT IT WAS SOILED WITH BLOOD). PATIENT INFORMATION: PATIENT'S CURRENT CONDITION: (B)(6). ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: (B)(6).
ADDITIONAL INFORMATION RECEIVED ON 12DEC24 1. WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? ="YES" 2. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN ="NO CONSEQUENCES, BUT THERE WAS A RISK OF A BLOOD EXPOSURE ACCIDENT." 3. WAS THE HCP PRESENT WHEN THE ISSUE OCCURRED? ="NO" 4. WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, PLEASE EXPLAIN ="NO" COULD YOU PLEASE SPECIFY THE DATE OF THE EVENT? "25/10/2024" 5. HAS THERE BEEN ANY HEALTHCARE WORKER¿S EXPOSURE TO BLOOD OR BODILY FLUIDS? 6. HAS THERE BEEN ANY ISSUE WITH SAFETY FEATURE? (RETRACTION FAILURES, SHIELDING FAILURES, SAFETY FEATURE FAILED TO COVER THE NEEDLE PROPERLY. INDICATE WHETHER THE FEATURE FAILED PRIOR TO USE OR DURING USE). 7. HAVE ANY OTHER ACTIONS BEEN TAKEN? ="INFORM NURSING STAFF + DEPARTMENT MANAGER. ADDITIONAL INFORMATION: EXPERIENCED NURSES" AS YOU HAVE MENTIONED THAT "THE RETRACTION SYSTEM DID NOT WORK ON 2 CATHETERS", PLEASE ANSWER THE BELOW QUESTIONS WITH REFERENCE TO THESE 2 CATHETERS. 8. CAN YOU CONFIRM WHETHER SAMPLES ARE AVAILABLE FOR THE SURVEY? IF YES, PLEASE SPECIFY IF SAMPLES ARE ="YES" UNUSED (BEFORE USE) USED (DURING OR AFTER USE) ="USED (DURING)" IMPORTANT: IF USED, PLEASE CONFIRM WHETHER THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. ="YES, PRESENCE OF THIS BLOOD." AS YOU HAVE MENTIONED THAT "AND WORKED WITH DIFFICULTY ON A 3RD CATHETER (WITH BLOOD SPLATTER)", PLEASE ANSWER THE BELOW QUESTIONS WITH REFERENCE TO THIS 3RD CATHETER. 9. CAN YOU CONFIRM WHETHER SAMPLES ARE AVAILABLE FOR THE SURVEY? IF YES, PLEASE SPECIFY IF SAMPLES ARE ="NO" UNUSED (BEFORE USE) USED (DURING OR AFTER USE) IMPORTANT: IF USED, PLEASE CONFIRM WHETHER THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. 10. IF YOU HAVE RETAINED A SAMPLE FOR INVESTIGATION, PLEASE PROVIDE US WITH THE COLLECTION ADDRESS (FULL DETAILS - PLEASE USE THE TEMPLATE BELOW). TO ENSURE EASY COLLECTION, WE STRONGLY RECOMMEND THAT YOU INDICATE AN EASILY ACCESSIBLE LOCATION, SUCH AS THE HOSPITAL PHARMACY, YOUR GOODS-IN/OUT DEPARTMENT, MAILROOM OR MAIN RECEPTION. THE ADDRESS SHOULD NOT BE INSIDE THE HOSPITAL UNIT (MATERNITY, ONCOLOGY, ETC.). A. COMPANY : "AGENCE GENERALE DES EQUIPEMENTS ET PRODUCTS DE SANTE (AGEPS)" B. COLLECTION POINT: (PHARMACY/INPUT/OUTPUT DEPARTMENT/MAIL ROOM/RECEPTION) = "SERVICE APPROVISIONNEMENT ET DISTRIBUTION (SAD)- CTR RECEPTION DOCK" (B)(6) G. COUNTRY: "FRANCE." 11. PLEASE ALSO PROVIDE US WITH THE TELEPHONE NUMBER OF A PERSON WHO CAN BE CONTACTED BY THE CARRIER. A. NAME OF CONTACT PERSON: "(B)(6)." B. TELEPHONE NUMBER: (B)(6). C. E-MAIL ADDRESS: (B)(6). "PLEASE GIVE THE CARRIER THE FOLLOWING RETURN NUMBER: (B)(6), WHICH MUST BE QUOTED AT THE TIME OF COLLECTION." 12. AN EMPTY SHIPPING BOX COMPLYING WITH REGULATIONS, ACCOMPANIED BY THE NECESSARY ACCESSORIES, WILL BE DELIVERED TO THE SAME ADDRESS. WE WILL ARRANGE FOR OUR CARRIER TO COLLECT THE SAMPLE.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2053779 | BD IAG BC PRO GLOBAL | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4152470 | 00382903810444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |