MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 5ML LL 21GA 1-1/4IN MX BUN

Catalog Number 302549

Device Problem Packaging Problem (3007)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the syringe 5ml ll 21ga 1-1/4in mx bun experienced damaged or open unit packaging/seal where sterility was compromised.The following information was provided by the initial reporter: 5ml bd syringe 21x 32 1 pc, lot 9338572, expiry date: 11/24.Packing with wrong cut.

Manufacturer Narrative

H6: investigation summary: photos received for investigation, the image shows a 5 ml syringe with the bister paper damage, where a cut in the shape of a zig zag can be observed, the cut is seen at the height of the plunger.A device history review was conducted for lot number 9338572 no quality events records in the product manufacture were found, the batch was inspected and later released accordance with the valid work instruction.Based on the photograph received, it can be concluded that the reported defect is not originated during the manufacturing process, since the cutting patterns shown in the photograph (zigzag) are not similar to the cutting patterns of the process (linear).The defect is not confirmed, therefore there is no root cause or corrective actions.H3 other text : see h10.

Event Description

It was reported that the syringe 5ml ll 21ga 1-1/4in mx bun experienced damaged or open unit packaging/seal where sterility was compromised.The following information was provided by the initial reporter: 5ml bd syringe 21x 32 1 pc lot 9338572 expiry date 11/24 packing with wrong cut.

• Brand Name: SYRINGE 5ML LL 21GA 1-1/4IN MX BUN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 11667855
• MDR Text Key: 261317979
• Report Number: 9614033-2021-00041
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302549
• Device Lot Number: 9338572
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1