UNSPECIFIED BD INTIMA-II NEEDLE
Report
- Report Number
- 3006948883-2020-00228
- Event Type
- Malfunction
- Date Received
- June 10, 2020
- Date of Event
- May 21, 2020
- Report Date
- August 24, 2020
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT UNSPECIFIED BD¿ INTIMA-II NEEDLE WAS BENT AND BLOOD LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO INDWELLING NEEDLE APPEARED QUALITY PROBLEM, ONE OF THEM WAS FOUND TO BE BENT IN THE PROCESS OF PUNCTURE AFTER THE PACKAGE WAS OPENED, AND THEN THE NEEDLE WAS REPLACED. AFTER THE REPLACEMENT OF THE INDWELLING NEEDLE WAS SUCCESSFULLY PUNCTURED, IT WAS FOUND THAT THERE WAS BLOOD LEAKAGE FROM THE TRANSPARENT SHELL AT THE UPPER END OF THE CATHETER WHEN THE BLOOD WAS RETURNED. THEN IT WAS PULLED OUT AND OBSERVED THAT THE TRANSPARENT SHELL AT THE UPPER END OF THE CATHETER HAD SMALL HOLE LIKE DAMAGE, RESULTING IN BLOOD LEAKAGE. UPDATED THE INFORMATION FROM THE SALES REP ON (B)(6) . HERE IS THE DETAIL: TWO NEEDLE APPEARED QUALITY PROBLEM, ONE OF THEM AFTER OPENING THE PACKAGE WAS FOUND THAT NEEDLE WAS BENT IN THE PROCESS OF PUNCTURE, SO IT WAS GIVEN REPLACEMENT OF INDWELLING NEEDLE TREATMENT, AFTER THE REPLACEMENT OF INDWELLING NEEDLE PUNCTURING WAS SUCCESSFUL. BUT IT WAS FOUND BLOOD LEAKAGE AT THE ADAPTER DURING BLOOD RETURNED PROCESS, THEN THEY PULLED OUT THE NEEDLE AND FOUND THAT THERE WAS THE DAMAGED WITH LITTLE HOLE AT THE NEEDLE HUB AFTER OBSERVATION . IT CAUSED THE LEAKAGE IN THIS COMPLAINT. D.1. MEDICAL DEVICE BRAND NAME: UNSPECIFIED BD¿ INTIMA-II NEEDLE UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.2. MEDICAL DEVICE CATALOG #: UNKNOWN D.4. UNIQUE IDENTIFIER (UDI) #: UNKNOWN G.5. PMA/510(K)#: UNKNOWN
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/31/2020. H.6. INVESTIGATION: UNFORTUNATELY A LOT NUMBER COULD NOT BE SUBMITTED FOR THIS COMPLAINT, AND COULD NOT BE DETERMINED FROM THE PHOTOGRAPHS PROVIDED. PREVENTING OUR INVESTIGATION TEAM FROM CONDUCTING A DEVICE HISTORY REVIEW. ADDITIONALLY, A SAMPLE WAS RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION. OUR INVESTIGATORS NOTED A SMALL CRACK WAS FOUND DURING LEAKAGE TESTING THAT WAS LOCATED ON THE ADAPTER. THE RETURNED PRODUCT'S SWAGE DIMENSIONS WERE MEASURED BY OUR TEAM AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. HOWEVER ACCORDING TO PREVIOUS INVESTIGATIONS, THROUGH A VARIANCE IN THE AUTOLINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO APPLY EXCESS FORCE TO THE DEVICE DURING ASSEMBLY, ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE. CURRENTLY, WE ARE CONDUCTING A LONG TERM STUDY, CAPA#642738, TO DETERMINE THE ROOT CAUSE FOR THIS EVENT, BUT WE ARE ADDRESSING THE ISSUE THROUGH THE IMPLEMENTATION OF MANUAL INSPECTION S FOR CRACKS IN THE ADAPTER HEAD, AND WE ARE FURTHER OPTIMIZING OUR SWAGING PROCESS BY REDUCING DEPTH REQUIREMENTS. OUR ENGINEERS ALSO NOTED THE PRESENCE OF A LARGE ANGLE BEND IN THE CANNULA OF THE SUBMITTED DEVICE. BASED ON PREVIOUS INVESTIGATION WE HAVE BEEN ABLE TO SHOW A CONNECTION BETWEEN THIS ISSUE AND THE TRANSPORTATION AND STORAGE CONDITIONS OF THE DEVICE.
IT WAS REPORTED THAT UNSPECIFIED BD¿ INTIMA-II NEEDLE WAS BENT AND BLOOD LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO INDWELLING NEEDLE APPEARED QUALITY PROBLEM, ONE OF THEM WAS FOUND TO BE BENT IN THE PROCESS OF PUNCTURE AFTER THE PACKAGE WAS OPENED, AND THEN THE NEEDLE WAS REPLACED. AFTER THE REPLACEMENT OF THE INDWELLING NEEDLE WAS SUCCESSFULLY PUNCTURED, IT WAS FOUND THAT THERE WAS BLOOD LEAKAGE FROM THE TRANSPARENT SHELL AT THE UPPER END OF THE CATHETER WHEN THE BLOOD WAS RETURNED. THEN IT WAS PULLED OUT AND OBSERVED THAT THE TRANSPARENT SHELL AT THE UPPER END OF THE CATHETER HAD SMALL HOLE LIKE DAMAGE, RESULTING IN BLOOD LEAKAGE. UPDATED THE INFORMATION FROM THE SALES REP ON (B)(6) . HERE IS THE DETAIL: TWO NEEDLE APPEARED QUALITY PROBLEM, ONE OF THEM AFTER OPENING THE PACKAGE WAS FOUND THAT NEEDLE WAS BENT IN THE PROCESS OF PUNCTURE, SO IT WAS GIVEN REPLACEMENT OF INDWELLING NEEDLE TREATMENT, AFTER THE REPLACEMENT OF INDWELLING NEEDLE PUNCTURING WAS SUCCESSFUL. BUT IT WAS FOUND BLOOD LEAKAGE AT THE ADAPTER DURING BLOOD RETURNED PROCESS, THEN THEY PULLED OUT THE NEEDLE AND FOUND THAT THERE WAS THE DAMAGED WITH LITTLE HOLE AT THE NEEDLE HUB AFTER OBSERVATION . IT CAUSED THE LEAKAGE IN THIS COMPLAINT.
IT WAS REPORTED THAT UNSPECIFIED BD¿ INTIMA-II NEEDLE WAS BENT AND BLOOD LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO INDWELLING NEEDLE APPEARED QUALITY PROBLEM, ONE OF THEM WAS FOUND TO BE BENT IN THE PROCESS OF PUNCTURE AFTER THE PACKAGE WAS OPENED, AND THEN THE NEEDLE WAS REPLACED. AFTER THE REPLACEMENT OF THE INDWELLING NEEDLE WAS SUCCESSFULLY PUNCTURED, IT WAS FOUND THAT THERE WAS BLOOD LEAKAGE FROM THE TRANSPARENT SHELL AT THE UPPER END OF THE CATHETER WHEN THE BLOOD WAS RETURNED. THEN IT WAS PULLED OUT AND OBSERVED THAT THE TRANSPARENT SHELL AT THE UPPER END OF THE CATHETER HAD SMALL HOLE LIKE DAMAGE, RESULTING IN BLOOD LEAKAGE. UPDATED THE INFORMATION FROM THE SALES REP ON 10, JUNE. HERE IS THE DETAIL: TWO NEEDLE APPEARED QUALITY PROBLEM, ONE OF THEM AFTER OPENING THE PACKAGE WAS FOUND THAT NEEDLE WAS BENT IN THE PROCESS OF PUNCTURE, SO IT WAS GIVEN REPLACEMENT OF INDWELLING NEEDLE TREATMENT, AFTER THE REPLACEMENT OF INDWELLING NEEDLE PUNCTURING WAS SUCCESSFUL. BUT IT WAS FOUND BLOOD LEAKAGE AT THE ADAPTER DURING BLOOD RETURNED PROCESS, THEN THEY PULLED OUT THE NEEDLE AND FOUND THAT THERE WAS THE DAMAGED WITH LITTLE HOLE AT THE NEEDLE HUB AFTER OBSERVATION . IT CAUSED THE LEAKAGE IN THIS COMPLAINT.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
IT WAS REPORTED THAT BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM NEEDLE WAS BENT AND BLOOD LEAKED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO INDWELLING NEEDLE APPEARED QUALITY PROBLEM, ONE OF THEM WAS FOUND TO BE BENT IN THE PROCESS OF PUNCTURE AFTER THE PACKAGE WAS OPENED, AND THEN THE NEEDLE WAS REPLACED. AFTER THE REPLACEMENT OF THE INDWELLING NEEDLE WAS SUCCESSFULLY PUNCTURED, IT WAS FOUND THAT THERE WAS BLOOD LEAKAGE FROM THE TRANSPARENT SHELL AT THE UPPER END OF THE CATHETER WHEN THE BLOOD WAS RETURNED. THEN IT WAS PULLED OUT AND OBSERVED THAT THE TRANSPARENT SHELL AT THE UPPER END OF THE CATHETER HAD SMALL HOLE LIKE DAMAGE, RESULTING IN BLOOD LEAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 605232 | UNSPECIFIED BD INTIMA-II NEEDLE | CATHETER | FPA | BECTON DICKINSON | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |