MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 20ML LL S/C 48; PISTON SYRINGE

Catalog Number 302830

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 20ml ll s/c 48 experienced foreign matter contamination.The following information was provided by the initial reporter: foreign material on the tip.

Event Description

It was reported that the syringe 20ml ll s/c 48 experienced foreign matter contamination.The following information was provided by the initial reporter: foreign material on the tip.

Manufacturer Narrative

H.6.Investigation: one sample was received by our quality team for investigation.Upon visual inspection, the sample came in an opened packaging blister and had embedded foreign matter on the luer tip and bottom part of the barrel.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause of the foreign matter is related to the barrel molding process during manufacturing.

• Brand Name: SYRINGE 20ML LL S/C 48
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8509039
• MDR Text Key: 142479576
• Report Number: 1911916-2019-00372
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028307
• UDI-Public: 30382903028307
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 302830
• Device Lot Number: 8332936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other