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

Catalog Number	305311
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2017
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 leak was observed from the bd integra¿ needle.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Correction: awareness date: from: date received by manufacturer: 12/01/2017.To: date received by manufacturer: 11/29/2017.
Additional Manufacturer Narrative
Additional information: multiple lot numbers were returned for evaluation: lot # 6263912 expiration date: 09/30/2021 manufacture date: 11/04/2016.Lot # 5302803 expiration date: 11/18/2015 manufacture date: 09/30/2020.Lot # 5287717 expiration date: 12/08/2015 manufacture date: 10/31/2020.Lot # 6263910 does not match the catalog number 305311 in the data base.No expiration date or manufacture date could be found.Investigation results: samples were received in the (b)(4) plant for evaluation.100 samples from batch 6263912 were leak tested with zero defects found.1 sample from batch 5302803 was leak tested with zero defects found.1 sample from batch 5287717 was leak tested with zero defects found.2 samples from batch 6263910 were leak tested with zero defects found.Failure mode was not duplicated therefore failure mode is not verified.Root cause could not be determined.A dhr was completed with zero defects found.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Based on the investigation results to date, root cause was not found.No formal corrective action is required at this time.

• Brand Name: BD INTEGRA¿ NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7140528
• Report Number: 1911916-2017-00372
• Device Sequence Number: 939282
• Product Code: MEG
• UDI-Device Identifier: 00382903053117
• UDI-Public: 00382903053117
• 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,Followup
• Report Date (Section B): 03/06/2018

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: 04/30/2019
• Device Catalogue Number: 305311
• Device Lot Number: 4121917
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 11/29/2017; 11/29/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/12/2018; 03/06/2018
• 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