MAUDE Adverse Event Report: BECTON DICKINSON BD PRECISIONGLIDE¿ NEEDLE; SYRINGE WITH NEEDLE

Catalog Number	305176
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
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 at an unknown occurrence, an bd precisionglide¿ needle was found with plastic debris on needles.There was no report of injury or medical intervention reported.
Additional Manufacturer Narrative
Investigation summary: a photo was received in the columbus plant for evaluation.The attached photo shows a plastic "thread" on the hub collar therefore failure mode is verified.This was possibly caused by the hub striking something during assembly.Dhr review: all in-process inspections show product to be within specification.No machine issues were noted.Investigation conclusion: one attached photo shows a plastic "thread" on the hub collar, possibly caused by the hub striking something during assembly.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7144229
• Report Number: 2243072-2017-00418
• Device Sequence Number: 1372596
• Product Code: FMF
• UDI-Device Identifier: 30382903051763
• UDI-Public: 30382903051763
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 03/01/2018

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: Physician
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 305176
• Device Lot Number: 6208860
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/22/2017
• 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