MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA¿ SYRINGE, 25 G X 1 IN RETRACTING NEEDLE; PISTON SYRINGE

Catalog Number	305311
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 a bd integra¿ syringe, 25 g x 1 in retracting needle was found leaking during use.There was no report of injury or medical intervention.
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.Dhr: 305311-5142547 conversion to 8000585 batches 4203842, 4307507, and 4273665.All batches were revised and no defects were found in dhr's.Based on the above, capa not necessary.

• Brand Name: BD INTEGRA¿ SYRINGE, 25 G X 1 IN 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: 6956190
• Report Number: 1911916-2017-00274
• Device Sequence Number: 745083
• Product Code: FMF
• UDI-Device Identifier: 30382903053118
• UDI-Public: 30382903053118
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• 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 Expiration Date: 05/31/2020
• Device Catalogue Number: 305311
• Device Lot Number: 5142547
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/17/2017
• 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