BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Report
- Report Number
- 9614033-2022-00091
- Event Type
- Malfunction
- Date Received
- October 25, 2022
- Date of Event
- September 30, 2022
- Report Date
- February 14, 2023
- Manufacturer
- BECTON DICKINSON DE MEXICO
- Product Code
- FMF
- UDI-DI
- 07501073025424
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY: ONE HUNDRED FIFTY SAMPLES OF 3 ML SYRINGES ARE RECEIVED IN THEIR PRIMARY PACKAGING IN A CARDBOARD BOX, LOT 2132661 WITH (B)(4) PIECES AND LOT 1337130 WITH (B)(4) PIECES, ADDITIONALLY THREE PHOTOS, AND ONE VIDEO ARE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION OF THE IMAGES, 3 ML SYRINGES IN THEIR PRIMARY PACKAGING WITH LOT NUMBERS 1337130 AND 2132661, CODE (B)(4) ARE OBSERVED. A VIDEO IS RECEIVED IN WHICH THE CLIENT IS SEEN HOLDING THE SYRINGE BY THE BASE OF THE RIM AND SLOWLY EXPELLING THE PLUNGER SIMULATING THE INTAKE OF LIQUID, WHERE IT CAN BE SEEN THAT THE PLUNGER RETURNS ON ITS OWN WHEN THE CLIENT RELEASES THIS PART OF THE DEVICE, THE CLIENT PERFORMS THE NEEDLE CHANGE TO SIMULATE A SECOND EXERCISE IN WHICH IT IS VISUALIZED THAT THE PLUNGER STAYS, THAT IS, IT DOES NOT RETURN ON ITS OWN TO THE BEGINNING OF THE SYRINGE. UPON VISUAL EVALUATION OF THE NEEDLES, NO DEFECTS OR ISSUES ARE OBSERVED. WHEN INTRODUCING THE STYLET INSIDE THE CANNULA, THERE IS RESISTANCE DUE TO PASTY CONSISTENCY INSIDE, NEEDLES APPEARED CLOGGED. FOURIER TRANSFORM INFRARED SPECTROSCOPY WAS PERFORMED TO FURTHER ANALYZE, FOREIGN SUBSTANCE IS SODIUM SALT, WHICH GENERATES THE FORMATION OF A PASTE THAT PREVENTS THE PASSAGE OF LIQUID THROUGH THE CANNULA. A DEVICE HISTORY RECORD REVIEW FOR THE CANNULA BATCHES SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE QUALITY TEAM'S INVESTIGATION, POSSIBLE ROOT CAUSE FOR CLOGGED NEEDLE IS ASSOCIATED WITH EFFECTIVENESS IN THE SENSOR AT THE ENTRANCE OF THE AUTO SHIELDER IN THE NIP LINE ENTRANCE.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1337130. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2026. DEVICE MANUFACTURE DATE: 15-MAR-2022. MEDICAL DEVICE LOT #: 2132661. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027. DEVICE MANUFACTURE DATE: 21-JUN-2022. 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 7 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES FROM LOT 1337130, AND 2 SYRINGES FROM LOT 2132661 WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "A CLIENT LEFT US 150 SYRINGES OF THE CODE 302542, SINCE HE TELLS US THAT THE MEDICINE DOES NOT PASS THROUGH THE NEEDLE, THEY ARE COVERED, HE HAS ALWAYS BOUGHT THE BD BRAND AND IT HAD NEVER HAPPENED TO HIM."
IT WAS REPORTED THAT 7 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES FROM LOT 1337130, AND 2 SYRINGES FROM LOT 2132661 WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "A CLIENT LEFT US 150 SYRINGES OF THE CODE 302542, SINCE HE TELLS US THAT THE MEDICINE DOES NOT PASS THROUGH THE NEEDLE, THEY ARE COVERED, HE HAS ALWAYS BOUGHT THE BD BRAND AND IT HAD NEVER HAPPENED TO HIM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2510147 | BD PLASTIPAK¿ LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON DE MEXICO | SEE H10 | 07501073025424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |