MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE; SYRINGE WITH NEEDLE

Catalog Number	305310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that before use a bd integra¿ syringe with retracting needle was found with black particles on the needle.There was no report of injury or medical intervention needed.
Additional Manufacturer Narrative
Investigation summary: no batch number was provided for a dhr/qn review.No sample or photos were available for analysis.Investigation conclusion: root cause could not be determined based on description, and no sample was available for investigation.

• Brand Name: BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7125897
• Report Number: 1911916-2017-00363
• Device Sequence Number: 1450453
• Product Code: MEG
• UDI-Device Identifier: 30382903053101
• UDI-Public: 30382903053101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other