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

Catalog Number	305311
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use, a bd integra¿ syringe retracting needle leaked out medication on the patient¿s arm.There was no report of injury or medical intervention needed.
Additional Manufacturer Narrative
Investigation results: no photos or samples were received in the columbus plant for evaluation therefore failure mode could not be verified and root cause could not be determined.A device history review was completed.305311-6263912 convert to batch 8000595/ 6231918 - was produced on 8/31/16 with zero defects found.No sample given to investigate or confirm.No root cause identified without sample.

• Brand Name: BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7124326
• Report Number: 1911916-2017-00371
• Device Sequence Number: 16680397
• Product Code: MEG
• UDI-Device Identifier: 30382903053118
• UDI-Public: 30382903053118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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 Expiration Date: 09/30/2021
• Device Catalogue Number: 305311
• Device Lot Number: 6263912
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 03/07/2018
• 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