BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Report
- Report Number
- 3003916417-2023-00208
- Event Type
- Malfunction
- Date Received
- August 8, 2023
- Date of Event
- July 19, 2023
- Report Date
- November 13, 2023
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, PRODUCT PACKAGING IS OBSERVED, NO DEFECTS OR ISSUES OBSERVED. UNABLE TO CONFIRM INCIDENT BASED ON IMAGES, PHYSICAL SAMPLE IS REQUIRED TO FURTHER ANALYZE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. RETENTION SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR ISSUES OBSERVED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. REGARDING THE LABEL CONTENT ISSUE, CATALOG 990687, THE REGISTRATION NUMBER IS DETAILED ON THE BACK LABEL OF THE SECONDARY PACKAGING.
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
WHEN INSPECTING THE SYRINGES WE IDENTIFIED THAT THE NEW PACKAGING CHANGES TO A PURPLE COLOR AND THE REFERENCE CODE IS THE SAME (REF: (B)(4)), ADDITIONALLY WE CAN PERCEIVE A SLIGHT DIFFERENCE IN THE RESISTANCE REQUIRED TO ACTUATE THE SYRINGE, WHICH CAUSES THE PERFUSOR TO REQUIRE MORE PRESSURE ON THE PLUNGER TO ADMINISTER THE MEDICATION, AND THIS TRIGGERS THE EQUIPMENT TO PRESENT THE SYSTEM ALARM. IMPORTANT: ON THE PACKAGING OF THE DEVICE, IT IS NOT POSSIBLE TO IDENTIFY THE HEALTH REGISTRATION NUMBER, NOR ANY OTHER INFORMATION REGARDING ITS IMPORTATION INTO MEXICO. DEFICIENCIES IN THE OPERATION, DIFFERENCE IN THE DESCRIPTION OF THE DEVICE, WITH RESPECT TO THE PREVIOUS CODE. DIFFERENCES BETWEEN THE COUNTRIES OF MANUFACTURE. NO INFORMATION ON THE EXPIRATION DATE. LACK OF SANITARY REGISTRATION, AT LEAST DESCRIBED IN THE PACKAGING OF THE DEVICE, SO I ALSO REQUEST SUPPORT TO VALIDATE THE DOCUMENTATION, AND THAT WE GET IT. THE LOT WITH WHICH WE PRESENT THE SITUATION IS: 2202309 (B)(4).
IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PACKAGING LABEL DID NOT IDENTIFY THE HEALTH REGISTRATION NUMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "WHEN INSPECTING THE SYRINGES WE IDENTIFIED THAT THE NEW PACKAGING CHANGES TO A PURPLE COLOR AND THE REFERENCE CODE IS THE SAME (REF: (B)(4)), ADDITIONALLY WE CAN PERCEIVE A SLIGHT DIFFERENCE IN THE RESISTANCE REQUIRED TO ACTUATE THE SYRINGE, WHICH CAUSES THE PERFUSOR TO REQUIRE MORE PRESSURE ON THE PLUNGER TO ADMINISTER THE MEDICATION, AND THIS TRIGGERS THE EQUIPMENT TO PRESENT THE SYSTEM ALARM. IMPORTANT: ON THE PACKAGING OF THE DEVICE, IT IS NOT POSSIBLE TO IDENTIFY THE HEALTH REGISTRATION NUMBER, NOR ANY OTHER INFORMATION REGARDING ITS IMPORTATION INTO MEXICO. DEFICIENCIES IN THE OPERATION, DIFFERENCE IN THE DESCRIPTION OF THE DEVICE, WITH RESPECT TO THE PREVIOUS CODE. DIFFERENCES BETWEEN THE COUNTRIES OF MANUFACTURE NO INFORMATION ON THE EXPIRATION DATE LACK OF SANITARY REGISTRATION, AT LEAST DESCRIBED IN THE PACKAGING OF THE DEVICE. THE LOT WITH WHICH WE PRESENT THE SITUATION IS: 2202309 FAB2022-08."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2325382 | BD PLASTIPAK¿ LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON IND. CIRURGICAS LTDA | 2202309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |