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

Catalog Number 300629

Device Problems Device Markings/Labelling Problem (2911); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd plastipak¿ syringe had foreign matter and a scale marking issue.No serious injury or medical intervention was reported.

Event Description

It was reported that bd plastipak¿ syringe had foreign matter and a scale marking issue.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation: two sample units belonging to lot number 1804274 were received for evaluation by our quality engineer.Through visual inspection of the first sample, foreign matter was not observed within the syringe or outside of the syringe.Through visual inspection of the second sample, a polypropylene particle was observed outside of the syringe, within the blister packaging.There were no signs of marking defects on either of the returned samples.A device history record review was performed and it did not reveal any detected quality issues during the production process that could have contributed to this incident.Polypropylene particles result from the molding and transport processes of the syringes.Based on the occurrence rate of this defect for the provided lot number, the acceptance criteria has not been exceeded.Within the assembly station, there is a de-ionizer which works to remove polypropylene particles from within the barrels.A quality project has been opened to reduce the presence of foreign matter inside of the blister packaging.A particle extractor is being installed in the packaging machine within the manufacturing line as part of this project.

• 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: 8199269
• MDR Text Key: 131916363
• Report Number: 3003152976-2018-00566
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other