MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE; BLOOD COLLECTION NEEDLE

Catalog Number 360213

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd had not received samples, but three (3) photos were provided for investigation.The photos were reviewed and the indicated failure mode for label lift was observed.The photos showed four (4) devices sticking to each other by the label corners that were lifting away from the device.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of label lift was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode of label lift based on returned photos.

Event Description

It was reported when using the bd vacutainer® precisionglide¿ multiple sample needle there was label lift off/partial peel off.The following information was provided by the initial reporter.The customer stated they "observed very regularly the paper sealing strips do not adhere completely to every needle, so they also stick to the nearest needle.".

• Brand Name: BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE
• Type of Device: BLOOD COLLECTION NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13119141
• MDR Text Key: 286007793
• Report Number: 9617032-2021-01341
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 360213
• Device Lot Number: 1088744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1