MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ SYRINGES; PISTON SYRINGE

Catalog Number 302542

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: six 3ml syringe samples and nine photos received by our quality team for investigation.Upon visual evaluation of the photos, syringes are displayed, no defects or issues can be observed.Physical samples were evaluated and clogged needle was observed.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.Clogged needle is associated with leak in epoxy dosing valve in the cannula-hub assembly process.Manufacturing personnel have been notified of this incident to increase awareness.Review of all needle assembly nozzles will be executed, and update to maintenance plan to include monthly review of needle- barrel assembly process.

Event Description

It was reported while using bd plastipak¿ syringes the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: medikat, a sub-distributor who buys from garis commercial service, reports that during the sampling it found material with deformation in the syringe, defective plunger seal and deformation in the tip thread.Photos attached.Additional information received by the client on 11/28/2022: number of defective syringes, deformed syringe thread - 548, syringe curvature - 35, content inside syringe - 4.Two new failures identified during investigation.Clogged needle and damaged shield.These incidents were found on (b)(6) 2023.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16628393
• MDR Text Key: 312300057
• Report Number: 9614033-2023-00029
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302542
• Device Lot Number: 2098973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1