MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA¿ SYRINGE, 25 G X 5/8 IN RETRACTING NEEDLE; SYRINGE WITH NEEDLE

Catalog Number	305310
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
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 while drawing up vaccine using a bd integra¿ syringe, 25 g x 5/8 in retracting needle, the device leaked.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Results: a sample is not available for evaluation.A review of the device history record revealed no qn.A total of 23 inspections were performed on 1150 parts and zero defects were found.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD INTEGRA¿ SYRINGE, 25 G X 5/8 IN 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: 6969418
• Report Number: 1911916-2017-00273
• Device Sequence Number: 497685
• Product Code: FMF
• UDI-Device Identifier: 30382903053101
• UDI-Public: 30382903053101
• 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,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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: 05/31/2021
• Device Catalogue Number: 305310
• Device Lot Number: 6139909
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 11/05/2017
• 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