MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 1ML 27GA 1/2IN; PISTON SYRINGE

Catalog Number 326716

Device Problems Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone# & email: (b)(6).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 20 syringe 1ml 27ga 1/2in had product and package damage with sterility issues.The following information was provided by the initial reporter : the customer reported that the syringes were with the cuts in the packaging, cylinder, plunger and support of the plunger.

Manufacturer Narrative

H.6.Investigation: during the documentary review of the batch 0332981 no quality events record in the product manufacture were found, the batch was inspected and later released accordance with the valid work instruction.The photographs are sent to the quality control laboratory where 5 pieces are judged with poor cut, ruling as non-compliant, however at the aql of 0.40% these pieces are within aql since there is a total of 7.7 ppm against an aql 4000ppm.An inappropriate cross-section defect is confirmed, potentially the root cause is the failure in the forming elevation sensor at the time of ordering the cutting and advancement a complaint lot history check was performed on lot # 0332981 for blisterpack damaged.This is the 1st related complaint for blisterpack damaged on lot # 0332981.

Event Description

It was reported that 20 syringe 1ml 27ga 1/2in had product and package damage with sterility issues.The following information was provided by the initial reporter : the customer reported that the syringes were with the cuts in the packaging, cylinder, plunger and support of the plunger.

• Brand Name: SYRINGE 1ML 27GA 1/2IN
• 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: 12145565
• MDR Text Key: 260984104
• Report Number: 9614033-2021-00078
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326716
• Device Lot Number: 0332981
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1