SYRINGE 10ML E/T 22G 1-1/2IN TW
Report
- Report Number
- 8041187-2020-00152
- Event Type
- Malfunction
- Date Received
- March 17, 2020
- Date of Event
- February 26, 2020
- Report Date
- April 16, 2020
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMF
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 30 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED PACKAGING TEARS WHILE OPENING LEAVING PAPER SHARDS IN A STERILE FIELD/ROOM WHILE ANOTHER 17 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED LIQUID OR MOISTURE TRANSFER THROUGH THE TOP WEB. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OUTER PACKAGING IS DIFFICULT TO TEAR BACK AND HAS BEEN WET WITH THE INFILTRATION PACKAGING. ADDITIONAL INFORMATION FROM THE CUSTOMER: THE MAIN NOTIFICATION ISSUES WERE THAT THE CUTTING LINE WAS NOT EASY TO TEAR. AT THE SAME TIME OF RECYCLING, IT WAS DETERMINED THAT THE RECOVERED PRODUCT HAD BEEN CONTAMINATED WITH UNKNOWN LIQUID, THE OUTER PACKAGING WAS ALREADY WET, AND IT WAS DETERMINED THAT THE MEDICAL STAFF WAS WORKING AT THE TIME OF RECYCLING SOMEONE WHO GOT WET DURING THE PROCESS ALSO RESPONDED TO THE HOSPITAL'S MATERIALS WINDOW, BUT THE MATERIALS WINDOW SAID THAT THE MEDICAL STAFF SAID THAT THE CUTTING LINES OF THIS BATCH ARE VERY DIFFICULT TO TEAR. THE CURRENT WINDOW ALSO INDICATES THAT I KNOW THAT THE PRODUCT I RETRIEVED IS WET, IT IS UNDERSTOOD THAT THERE IS NO PROBLEM IN THE STORAGE ENVIRONMENT OF THE USER FACILITY. IT SHOULD BE THAT THE MEDICAL STAFFS HAVE ACCIDENTALLY CAUSED THE PRODUCT TO GET WET WHEN THEY ARE WORKING ON THE WORKBENCH. H3 OTHER TEXT : SEE H.10.
THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT (B)(4) SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED POOR PERFORATION ON PACKAGING WHILE ANOTHER (B)(4) SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED LIQUID OR MOISTURE TRANSFER THROUGH THE TOP WEB. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OUTER PACKAGING IS DIFFICULT TO TEAR BACK AND HAS BEEN WET WITH THE INFILTRATION PACKAGING. ADDITIONAL INFORMATION FROM THE CUSTOMER: THE MAIN NOTIFICATION ISSUES WERE THAT THE CUTTING LINE WAS NOT EASY TO TEAR. AT THE SAME TIME OF RECYCLING, IT WAS DETERMINED THAT THE RECOVERED PRODUCT HAD BEEN CONTAMINATED WITH UNKNOWN LIQUID, THE OUTER PACKAGING WAS ALREADY WET, AND IT WAS DETERMINED THAT THE MEDICAL STAFF WAS WORKING AT THE TIME OF RECYCLING SOMEONE WHO GOT WET DURING THE PROCESS ALSO RESPONDED TO THE HOSPITAL'S MATERIALS WINDOW, BUT THE MATERIALS WINDOW SAID THAT THE MEDICAL STAFF SAID THAT THE CUTTING LINES OF THIS BATCH ARE VERY DIFFICULT TO TEAR. THE CURRENT WINDOW ALSO INDICATES THAT I KNOW THAT THE PRODUCT I RETRIEVED IS WET, IT IS UNDERSTOOD THAT THERE IS NO PROBLEM IN THE STORAGE ENVIRONMENT OF THE USER FACILITY. IT SHOULD BE THAT THE MEDICAL STAFFS HAVE ACCIDENTALLY CAUSED THE PRODUCT TO GET WET WHEN THEY ARE WORKING ON THE WORKBENCH.
ADDITIONAL INFORMATION D.10 SAMPLES RECEIVED: (B)(6) 2020 DEVICE EVALUATION H.6. INVESTIGATION SUMMARY ONE PHOTO AND 31 ACTUAL SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, IT WAS OBSERVED THAT THERE WAS INDIVIDUAL AND TORN BLISTER PACKAGES DUE TO DIFFICULT TO TEAR ISSUE. UPON VISUAL INSPECTION OF THE SAMPLES. IT WAS OBSERVED THAT THERE WAS UNCLEAR PERFORATION CUT LINES IN BETWEEN THE BLISTER PACKAGES AND THAT THERE WAS DAMAGED PACKAGING. IT WAS ALSO OBSERVED THAT THERE WAS A DARK-GREENISH STAIN MARK ON THE TOP WEB SURFACE FROM THE SAMPLES OF BATCH 8142299. THE INCIDENT COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. AT THE PACKAGING PERFORATION STATION, THERE IS A PERFORATION KNIFE TO CREATE PERFORATED CUTS. BASED ON THE INVESTIGATION, THE PROBABLE ROOT CAUSE COULD BE DUE TO THE PERFORATION KNIFE WEAR AND TEAR, CAUSING THE UNCLEAR PERFORATION CUT LINES AND THE PRODUCTION TECHNICIAN MAY HAVE BEEN UNABLE TO DETECT THE GOOD AND BAD PERFORATION CUT LINES, HENCE PARTS FLOW TO NEXT PROCESS. FOR THE DARK GREENISH STAIN MARK, IT WAS REPORTED IN THE VERBATIM THAT THE SAMPLE HAD BEEN CONTAMINATED WITH UNKNOWN LIQUID. THE DARK GREENISH STAIN MARK COULD HAVE BEEN CONTAMINATED WITH THE UNKNOWN LIQUID.; HENCE, THAT NON-CONFORMANCE COULD HAVE OCCURRED OUTSIDE OF THE MANUFACTURING FACILITY. 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.
IT WAS REPORTED THAT 30 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED PACKAGING TEARS WHILE OPENING LEAVING PAPER SHARDS IN A STERILE FIELD/ROOM WHILE ANOTHER 17 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED LIQUID OR MOISTURE TRANSFER THROUGH THE TOP WEB. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OUTER PACKAGING IS DIFFICULT TO TEAR BACK AND HAS BEEN WET WITH THE INFILTRATION PACKAGING. ADDITIONAL INFORMATION FROM THE CUSTOMER: THE MAIN NOTIFICATION ISSUES WERE THAT THE CUTTING LINE WAS NOT EASY TO TEAR. AT THE SAME TIME OF RECYCLING, IT WAS DETERMINED THAT THE RECOVERED PRODUCT HAD BEEN CONTAMINATED WITH UNKNOWN LIQUID, THE OUTER PACKAGING WAS ALREADY WET, AND IT WAS DETERMINED THAT THE MEDICAL STAFF WAS WORKING AT THE TIME OF RECYCLING SOMEONE WHO GOT WET DURING THE PROCESS ALSO RESPONDED TO THE HOSPITAL'S MATERIALS WINDOW, BUT THE MATERIALS WINDOW SAID THAT THE MEDICAL STAFF SAID THAT THE CUTTING LINES OF THIS BATCH ARE VERY DIFFICULT TO TEAR. THE CURRENT WINDOW ALSO INDICATES THAT I KNOW THAT THE PRODUCT I RETRIEVED IS WET, IT IS UNDERSTOOD THAT THERE IS NO PROBLEM IN THE STORAGE ENVIRONMENT OF THE USER FACILITY. IT SHOULD BE THAT THE MEDICAL STAFFS HAVE ACCIDENTALLY CAUSED THE PRODUCT TO GET WET WHEN THEY ARE WORKING ON THE WORKBENCH.
IT WAS REPORTED THAT 30 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED POOR PERFORATION ON PACKAGING WHILE ANOTHER 17 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED LIQUID OR MOISTURE TRANSFER THROUGH THE TOP WEB. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OUTER PACKAGING IS DIFFICULT TO TEAR BACK AND HAS BEEN WET WITH THE INFILTRATION PACKAGING. ADDITIONAL INFORMATION FROM THE CUSTOMER: THE MAIN NOTIFICATION ISSUES WERE THAT THE CUTTING LINE WAS NOT EASY TO TEAR. AT THE SAME TIME OF RECYCLING, IT WAS DETERMINED THAT THE RECOVERED PRODUCT HAD BEEN CONTAMINATED WITH UNKNOWN LIQUID, THE OUTER PACKAGING WAS ALREADY WET, AND IT WAS DETERMINED THAT THE MEDICAL STAFF WAS WORKING AT THE TIME OF RECYCLING SOMEONE WHO GOT WET DURING THE PROCESS ALSO RESPONDED TO THE HOSPITAL'S MATERIALS WINDOW, BUT THE MATERIALS WINDOW SAID THAT THE MEDICAL STAFF SAID THAT THE CUTTING LINES OF THIS BATCH ARE VERY DIFFICULT TO TEAR. THE CURRENT WINDOW ALSO INDICATES THAT I KNOW THAT THE PRODUCT I RETRIEVED IS WET, IT IS UNDERSTOOD THAT THERE IS NO PROBLEM IN THE STORAGE ENVIRONMENT OF THE USER FACILITY. IT SHOULD BE THAT THE MEDICAL STAFFS HAVE ACCIDENTALLY CAUSED THE PRODUCT TO GET WET WHEN THEY ARE WORKING ON THE WORKBENCH.
IT WAS REPORTED THAT 30 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED PACKAGING TEARS WHILE OPENING LEAVING PAPER SHARDS IN A STERILE FIELD/ROOM WHILE ANOTHER 17 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED LIQUID OR MOISTURE TRANSFER THROUGH THE TOP WEB. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OUTER PACKAGING IS DIFFICULT TO TEAR BACK AND HAS BEEN WET WITH THE INFILTRATION PACKAGING.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9200978. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-19. MEDICAL DEVICE LOT #: 8142299. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-05-22. 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 30 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED PACKAGING TEARS WHILE OPENING LEAVING PAPER SHARDS IN A STERILE FIELD/ROOM WHILE ANOTHER 17 SYRINGES 10ML E/T 22G 1-1/2IN TW EXPERIENCED LIQUID OR MOISTURE TRANSFER THROUGH THE TOP WEB. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OUTER PACKAGING IS DIFFICULT TO TEAR BACK AND HAS BEEN WET WITH THE INFILTRATION PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309242 | SYRINGE 10ML E/T 22G 1-1/2IN TW | SYRINGE | FMF | BECTON DICKINSON MEDICAL (SINGAPORE) | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |