MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 20ML ENTERAL SYRINGE, BULK NON-STERILE

Catalog Number 305860

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

Results: one unit was received for evaluation.Our quality engineer microscopically inspected the returned unit and confirmed that foreign matter was embedded into the syringe barrel.The foreign was identified as over-processed polypropylene.A complaint history check revealed no similar incidents for reported lot number 6201790.Conclusion: bd was able to confirm the reported incident.The engineer concludes that the foreign was likely introduced during the molding process.(b)(4).

Event Description

The customer observed a reddish-brown discoloration inside the syringe barrel of the 20ml bd enteral syringe.

• Brand Name: BD 20ML ENTERAL SYRINGE, BULK NON-STERILE
• Type of Device: ENTERAL SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6753775
• MDR Text Key: 81569212
• Report Number: 1911916-2017-00109
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 305860
• Device Lot Number: 6201790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other