BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT
Report
- Report Number
- 2243072-2022-00322
- Event Type
- Malfunction
- Date Received
- March 9, 2022
- Date of Event
- February 24, 2022
- Report Date
- March 29, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- UDI-DI
- 00382903054879
- PMA / PMN Number
- K943139
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: THE DHR REVIEW PROCESS CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED FOR HIS REPORT NUMBER. A REVIEW OF THE HISTORICAL NCMR¿S FOR THE AFFECTED COMPONENT (LID) UNDER PART NUMBER BDX-8990020 WAS MADE AND IT WAS FOUND THAT 6 NCS WERE GENERATED FOR THE SAME DEFECT IN THE LAST 5 YEARS, THE VERY LAST EVENT WAS REPORTED BACK IN THE LAST YEAR. ACCORDING TO THE PHOTOS RECEIVED FROM CUSTOMER, IT CAN BE SEEN THE FOLLOWING: THERE IS AN OBSTRUCTION BY EXCESS OF PLASTIC MATERIAL ON LID¿S SKIRT, WHICH SEEMS TO BE GENERATED BY A BROKEN INSERT IN THE MOLD. HENCE, THE LID CAN¿T FIT THE BASE WHEN TRYING TO ASSEMBLY BY END USER. ACCORDING WITH THIS EVIDENCE, WE CAN DETERMINE THIS ISSUE AS A MANUFACTURING RELATED TOPIC SINCE THIS KIND OF ISSUES ARE GENERATED DUE TO A DAMAGED ON THE MOLD (BROKEN INSERT) DURING THE INJECTION MOLDING PROCESS. AS PART OF THIS INVESTIGATION, A REVIEW OF CUSTOMER COMPLAINT RECORDS WAS CONDUCTED AND ACCORDING TO PREVIOUS CC RECORD, AT THE TIME WHERE THIS INVESTIGATION TOOK PLACE IT WAS REPORTED MORE EVENTS IN WHERE THE SAME PIECE OF PLASTIC WAS STICK TO THE LID. BASED ON ABOVE EVIDENCE, THE ROOT CAUSE WHY THE EVENT HAPPENED AND THE MOTIVE WHY THE PARTS WERE SENT OUT ARE: OCCURRENCE. MOLD INSERTS BROKEN SINCE MOLD ACHIEVED THE END OF LIFE (DOUBLED THE DESIGN QUANTITY REQUIREMENTS) AND LIFE CYCLE HAS BEEN EXCEEDED; IN OTHER WORDS, THE TOOL WORN OUT/DESIGN LEADED TO THE STEEL FAILURE. THE FAILURE INDICATES THAT MOLD DESIGN IS ANOTHER FACTOR THAT CONTRIBUTE TO THE DAMAGES ON THE MOLD INSERTS BECAUSE THE DESIGN OF THOSE INSERTS HAS TWO ASYMMETRIC TABS AND THE DAMAGE ALWAYS OCCUR ON THE THINNER TAB.
IT WAS REPORTED WHILE USING BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT THE LID WAS BROKEN AND DID NOT CLOSE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S VERBATIM REPORT IS THAT ONE OF THE CLAWS ON THE LID WAS BROKEN AND THE LID DID NOT SHUT.
IT WAS REPORTED WHILE USING BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT THE LID WAS BROKEN AND DID NOT CLOSE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER'S VERBATIM REPORT IS THAT ONE OF THE CLAWS ON THE LID WAS BROKEN AND THE LID DID NOT SHUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2659913 | BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON | 305487 | UNKNOWN | 00382903054879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |