MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMICLUMEN NEEDLE

Catalog Number 305122

Device Problems Inadequacy of Device Shape and/or Size (1583); Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that before use of the bd precisionglide¿ needle, "it was reported that there are two different size needles within the same package." no report of serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: a photo was received for evaluation.A review of the attached photo confirms there are 25g 1¿ needles packaged with 25g 5/8¿ needles in 25g 5/8 packaging therefore failure mode is verified.It¿s possible an operator manually dumped the incorrect needle length into a product hopper.All operators were re-trained to scan material identification tags prior to use.This re- training was performed june 7, 2018.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.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.Investigation conclusion: because nothing could be confirmed within the batch record, it¿s possible an operator manually dumped the incorrect needle length into a product hopper.

Event Description

It was reported that before use of the bd precisionglide¿ needle, "it was reported that there are two different size needles within the same package." no report of serious injury or medical intervention.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Type of Device: HYPODERMICLUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7650384
• MDR Text Key: 113191257
• Report Number: 1911916-2018-00345
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: 30382903051220
• Combination Product (y/n): N
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 305122
• Device Lot Number: 7236556
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other