MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD PERCISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305185
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.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 percisionglide¿ needles are coring rubber stoppers.This occurred on 30 separate occasions but the date/time and or patient information is unknown.
Additional Manufacturer Narrative
Additional information: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8117700.Medical device expiration date: 6/30/2023.Device manufacture date: 4/27/2018.Medical device lot #: 8205842.Medical device expiration date: 9/30/2023.Device manufacture date: 7/24/2018.Investigation summary: a total of 335 samples were received from both lot#s.A random sample of 30 units were taken from both lot#s.The coring test was performed on the random samples.They were 2 or less; the specification is 3 or less.They passed testing and failure mode is not verified.Root cause could not be determined.A total of 335 samples were received from both lot#s.A random sample of 30 units were taken from both lot#s, the coring test was performed on the random samples, they were 2 or less, the specification is 3 or less.They passed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
Event or Problem Description
It was reported that a bd percisionglide¿ needles are coring rubber stoppers.This occurred on 30 separate occasions but the date/time and or patient information is unknown.

• Brand Name: BD PERCISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8265439
• Report Number: 1911916-2019-00002
• Device Sequence Number: 19382899
• Product Code: FMI
• UDI-Device Identifier: 00382903051854
• UDI-Public: 382903051854
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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 Catalogue Number: 305185
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 03/06/2019
• 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