BD SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN
Report
- Report Number
- 3006948883-2025-00207
- Event Type
- Malfunction
- Date Received
- June 17, 2025
- Date of Event
- May 18, 2025
- Report Date
- July 16, 2025
- Manufacturer
- BD SUZHOU (MDS)
- Product Code
- FOZ
- UDI-DI
- 00382903833191
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT/BATCH NUMBER INFORMATION IS NOT AVAILABLE. A DHR/BHR REVIEW COULD NOT BE PERFORMED AS THE LOT/BATCH NUMBER INFORMATION IS NOT AVAILABLE. RETAIN SAMPLE ANALYSIS COULD NOT BE PERFORMED AS THE LOT/BATCH NUMBER INFORMATION IS NOT AVAILABLE. THERE IS A PHOTO PROVIDED, BUT THE DEFECT FEATURE COULD NOT BE OBSERVED IN THE PHOTOGRAPH PROVIDED. BASED ON THE DESCRIPTION, CUSTOMER INSERTED A PRIMED DEVICE INTO PATIENT AND WHEN RETRACTING, THE NEEDLE CAME OUT OF THE DEVICE TUBING AND CAUSED THE INJURY. THE POSSIBLE CAUSE IS, AFTER FINISHING THE PUNCTURE, DUE TO IMPROPER NEEDLE WITHDRAWAL TECHNIQUE-SPECIFICALLY, FAILURE TO MAINTAIN A STRAIGHT TRAJECTORY AND AN UNINTENDED PAUSE WITH RELEASE OF GRIP, THE NEEDLE ADVANCED FORWARD AND PERFORATED THE CATHETER. NEEDLE PERFORATION OF THE CATHETER IS GENERALLY NOT EXPECTED TO OCCUR DURING PROPER NEEDLE WITHDRAWAL PROCEDURES. THIS CASE IS HIGHLY POSSIBLE, CAUSED DUE TO CUSTOMER IMPROPER NEEDLE WITHDRAWAL OPERATION.
IT WAS REPORTED THAT BD SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN NEEDLE THROUGH CATHETER IT WAS REPORTED BY THE CUSTOMER THAT WHEN RETRACTING THE NEEDLE CAME OUT OF THE DEVICE TUBING AND CAUSED A NEEDLE STICKY INJURY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. NURSE INSERTING PRIMED DEVICE INTO PATIENT AND WHEN RETRACTING THE NEEDLE CAME OUT OF THE DEVICE TUBING AND CAUSED A NEEDLE STICKY INJURY. PRODUCT#: 383319 ADDITIONAL INFORMATION: KINDLY PROVIDE THE BATCH/LOT NUMBER OF THE PRODUCT. WE DO NOT HAVE THIS INFORMATION AS THE PACKAGING WAS THROWN OUT BEFORE THE INCIDENT BY THE STAFF MEMBER. WE HAVE INSTRUCTED ALL STAFF IN THE FUTURE TO RETAIN PACKAGING. PLEASE CONFIRM IF THE COMPLAINT UNIT IS AVAILABLE FOR RETURN. THE SHIPPING LABEL PROVIDED SHOWS THE PACKAGE HAS NOT BEEN PICKED UP YET. THE UNIT WAS 4BD CTU BUT SHOULD BE SENT TO BIO MED I ASSUME, NOT THE MEDICAL UNIT WHERE THE INCIDENT TOOK PLACE. PLEASE PROVIDE, TO AID IN OUR INVESTIGATION, A PICTURE/VIDEO FROM THE TIME OF THE REPORTED EVENT. I HAVE ATTACHED A PICTURE AND REPORT WITH MORE INFORMATION. DATE OF OCCURRENCE: (B)(6) 2025 TIME OF OCCURRENCE: 2000 DATE REPORTED: 2025-05-18 TIME REPORTED: 2330 DID THE AFFECTED PERSONNEL REQUIRE MEDICAL INTERVENTION/SCREENING FOR THE NEEDLE STICK INJURY? IF YES, PLEASE PROVIDE DETAILS. YES, THEY WENT TO THE EMERGENCY ROOM IMMEDIATELY FOR ASSESSMENT AND BLOODWORK. THE PATIENT ALSO RECEIVED BLOOD WORK. WAS THERE ANY NEGATIVE HEALTH CONSEQUENCES OR IMPACT TO PATIENT HEALTH/TREATMENT AS A RESULT OF THIS EVENT? IF YES, PLEASE PROVIDE DETAILS. THE PATIENT REQUIRED TO HAVE THEIR BLOOD TAKEN AS A RESULT OF THIS INCIDENT. WE STRIVE TO LIMIT THE NUMBER OF TIMES A PATIENT IS POKED OR BLOOD TAKEN AND THIS INCIDENT LED TO THEM HAVING TO HAVE THIS OCCUR.
NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1628748 | BD SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN | INTRAVASCULAR CATHETER | FOZ | BD SUZHOU (MDS) | UNKNOWN | 00382903833191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |