MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 20ML LL S/C 50; PISTON SYRINGE

Catalog Number 303310

Device Problem Packaging Problem (3007)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

Medwatch report # (b)(4).Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe 20ml ll s/c 50 packaging split and tore.The following information was provided by the initial reporter: material no.: 303310.Batch no.: 0098739.It was reported the packaging splits and tears when attempting to open which compromised the sterility.Per medwatch: the packaging of this 20ml luer lock syringe splits and rips when attempting to open and deliver the device to the sterile surgical field, contaminating the syringe.This is a sterile product however packaging does not allow the product to be removed in a way that maintains sterility.

Manufacturer Narrative

H.6.Investigation: three samples received for investigation, upon observation it is possible to see the torn packaging.It is observed that the opening is not correct, however, we cannot give a concrete opinion since it is not possible to perform the peel primary packaging test since the samples provided were tampered with.Root cause cannot be determined since the physical samples arrived open, therefore there are no corrective actions.During the documentary review of the batch 0098739 no quality events records in the product manufacture were found, the batch was inspected and later released accordance with the valid work instruction.Complaint history check was performed, this is the 1st reported incident of package difficult to open/tears on lot 0098739.

Event Description

It was reported that syringe 20ml ll s/c 50 packaging split and tore.The following information was provided by the initial reporter: material no.: 303310 batch no.: 0098739 it was reported the packaging splits and tears when attempting to open which compromised the sterility.Per medwatch: the packaging of this 20ml luer lock syringe splits and rips when attempting to open and deliver the device to the sterile surgical field, contaminating the syringe.This is a sterile product however packaging does not allow the product to be removed in a way that maintains sterility.

• Brand Name: SYRINGE 20ML LL S/C 50
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 11853235
• MDR Text Key: 259703297
• Report Number: 9614033-2021-00060
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303310
• Device Lot Number: 0098739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1