MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK SYRINGE

Catalog Number 300865

Device Problem Fungus in Device Environment (2316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

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 there was mold in the bd plastipak¿ syringe.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: mold in the syringe.

Manufacturer Narrative

Investigation summary: one unused sample was received by our quality engineer for evaluation.Upon visual inspection of the sample, a matter was observed outside the syringe, at the barrel edge.Further inspection determined the particles consisted of polypropylene particles that attached to the syringe.A device history review was performed for reported lot 1902220, no deviations or non-conformances related to the reported issues were identified during the manufacturing process.While we could not identify a direct issue, it was determined this instance occurred as a result of the polypropylene particles generating during the transport of the product within the manufacturing line and attaching to the syringe.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.We have recently implemented a vacuum system to reduce the presence of foreign matter within the blister, the reported lot manufactured prior to the use of this system.Manufacturing personnel have been made aware of your experience to increase awareness of this matter.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.

Event Description

It was reported that there was mold in the bd plastipak¿ syringe foreign complaint the following information was provided by the initial reporter, translated from german to english: mold in the syringe.

• Brand Name: BD PLASTIPAK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8670409
• MDR Text Key: 147190289
• Report Number: 3003152976-2019-00380
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 300865
• Device Lot Number: 1902220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other