BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Report
- Report Number
- 3014704491-2023-00570
- Event Type
- Injury
- Date Received
- September 19, 2023
- Date of Event
- August 28, 2023
- Report Date
- September 28, 2023
- Manufacturer
- BD (SUZHOU)
- Product Code
- FOZ
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL? YES. D.9. RETURNED TO MANUFACTURER ON: 07-SEP-2023. H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER: 3080077. 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, A SAMPLE WAS RETURNED TO AID IN OUR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE WAS ABLE TO CONFIRM THE REPORTED SEPARATION OF THE CATHETER TUBING FROM THE Y-ADAPTER. THE BROKEN EDGE OF THE TUBING WAS SMOOTH AND DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP CUTTING IMPLEMENT BEING APPLIED TO THE TUBING. FUNCTIONAL TESTING WAS NOT PERFORMED ON THE DEVICE DUE TO THE DAMAGED STATE IT WAS RETURNED IN. IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT; THE RESULTS SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, OUR ENGINEERS WERE NOT ABLE TO DETERMINE THE ROOT CAUSE FOR THIS EVENT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
E.1. INITIAL REPORTER PHONE #: (B)(6). H3. 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 THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM SEPARATED AND LEAKED DURING USE. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: AT 13:00 ON (B)(6) 2023, THE FAMILY OF THE CHILD COMPLAINED THAT WHEN THE CHILD MOVED HIS LEFT WRIST, BLOOD SUDDENLY FLOWED OUT FROM THE SUPERFICIAL VEIN CATHETERIZATION SITE, WITH A VOLUME OF 5ML. THE FAMILY MEMBERS IMMEDIATELY WRAPPED THEM IN A TISSUE TO STOP THE BLEEDING AND CALLED THE NURSE, WHO IMMEDIATELY CHECKED THE CONDITION OF THE INDWELLING NEEDLE. IT WAS FOUND THAT THE PUNCTURE SITE OF THE CHILD WAS STILL BLEEDING, AND PART OF THE APPLICATION AT THE PUNCTURE SITE WAS MISSING AND THE HOSE OF THE INDWELLING NEEDLE WAS MISSING, WITH A LENGTH OF ABOUT 1.6 CM. IMMEDIATELY BIND THE PROXIMAL END OF THE TOURNIQUET ON THE LEFT UPPER ARM AND PRESS TO STOP THE BLEEDING AND CALL THE ATTENDANT. AFTER CONSULTING THE SUPERIOR PHYSICIAN, IMMEDIATELY ACCOMPANY THE FAMILY MEMBERS TO TAKE THE CHILD TO THE B-ULTRASOUND ROOM FOR LEFT WRIST BLOOD VESSEL COLOR ULTRASOUND EXAMINATION, AND REPORT TO THE DEPARTMENT DIRECTOR, NURSE AND MEDICAL DEPARTMENT. AFTER REPEATED EXAMINATION BY COLOR DOPPLER ULTRASOUND, NO FOREIGN BODY IN THE BLOOD VESSEL WAS FOUND. THE CHILD WAS TAKEN TO THE IMAGING DEPARTMENT FOR 64-SLICE CT EXAMINATION, AND NO FOREIGN BODY IN THE BLOOD VESSEL WAS FOUND IN THE CT EXAMINATION. ASK THE PATIENT CAREFULLY AGAIN. DURING THE CHILD'S SELF-REPORTING ACTIVITIES, HE FOUND THAT THE INDWELLING NEEDLE WAS BROKEN. THE CHILD WAS WORRIED ABOUT THE RESIDUAL HOSE, SO HE QUICKLY PULLED OUT THE RESIDUAL HOSE AND DISCARDED IT IN THE TRASH CAN. AFTER SEARCHING, HE DID NOT FIND THE DISCARDED HOSE. AFTER COMPLETING VARIOUS INSPECTIONS, TAKE THE CHILD BACK TO THE WARD. THE GENERAL CONDITION AND SPIRIT OF THE CHILD ARE FINE. SELF-REPORT WHETHER THERE IS ANY DISCOMFORT, GIVE LYING PRESSURE REST, REDUCE STRENUOUS EXERCISE, AND CLOSELY COOPERATE TO OBSERVE WHETHER THE CHILD HAS ANY DISCOMFORT, AND THEN OBSERVE THE VITAL SIGNS.
IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM SEPARATED AND LEAKED DURING USE. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: AT 13:00 ON (B)(6) 2023, THE FAMILY OF THE CHILD COMPLAINED THAT WHEN THE CHILD MOVED HIS LEFT WRIST, BLOOD SUDDENLY FLOWED OUT FROM THE SUPERFICIAL VEIN CATHETERIZATION SITE, WITH A VOLUME OF 5ML. THE FAMILY MEMBERS IMMEDIATELY WRAPPED THEM IN A TISSUE TO STOP THE BLEEDING AND CALLED THE NURSE, WHO IMMEDIATELY CHECKED THE CONDITION OF THE INDWELLING NEEDLE. IT WAS FOUND THAT THE PUNCTURE SITE OF THE CHILD WAS STILL BLEEDING, AND PART OF THE APPLICATION AT THE PUNCTURE SITE WAS MISSING AND THE HOSE OF THE INDWELLING NEEDLE WAS MISSING, WITH A LENGTH OF ABOUT 1.6 CM. IMMEDIATELY BIND THE PROXIMAL END OF THE TOURNIQUET ON THE LEFT UPPER ARM AND PRESS TO STOP THE BLEEDING AND CALL THE ATTENDANT. AFTER CONSULTING THE SUPERIOR PHYSICIAN, IMMEDIATELY ACCOMPANY THE FAMILY MEMBERS TO TAKE THE CHILD TO THE B-ULTRASOUND ROOM FOR LEFT WRIST BLOOD VESSEL COLOR ULTRASOUND EXAMINATION, AND REPORT TO THE DEPARTMENT DIRECTOR, NURSE AND MEDICAL DEPARTMENT. AFTER REPEATED EXAMINATION BY COLOR DOPPLER ULTRASOUND, NO FOREIGN BODY IN THE BLOOD VESSEL WAS FOUND. THE CHILD WAS TAKEN TO THE IMAGING DEPARTMENT FOR 64-SLICE CT EXAMINATION, AND NO FOREIGN BODY IN THE BLOOD VESSEL WAS FOUND IN THE CT EXAMINATION. ASK THE PATIENT CAREFULLY AGAIN. DURING THE CHILD'S SELF-REPORTING ACTIVITIES, HE FOUND THAT THE INDWELLING NEEDLE WAS BROKEN. THE CHILD WAS WORRIED ABOUT THE RESIDUAL HOSE, SO HE QUICKLY PULLED OUT THE RESIDUAL HOSE AND DISCARDED IT IN THE TRASH CAN. AFTER SEARCHING, HE DID NOT FIND THE DISCARDED HOSE. AFTER COMPLETING VARIOUS INSPECTIONS, TAKE THE CHILD BACK TO THE WARD. THE GENERAL CONDITION AND SPIRIT OF THE CHILD ARE FINE. SELF-REPORT WHETHER THERE IS ANY DISCOMFORT, GIVE LYING PRESSURE REST, REDUCE STRENUOUS EXERCISE, AND CLOSELY COOPERATE TO OBSERVE WHETHER THE CHILD HAS ANY DISCOMFORT, AND THEN OBSERVE THE VITAL SIGNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1747883 | BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM | INTRAVASCULAR CATHETER | FOZ | BD (SUZHOU) | 3080077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |