MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD NEEDLE 20GA 1-1/2IN BIL LAX; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 302350

Device Problem Contamination (1120)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

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 the bd needle 20ga 1-1/2in bil lax was dirty with machine grease.The following information was provided by the initial reporter, translated from spanish to english: 1 piece dirty.

Manufacturer Narrative

H6: investigation summary: one photo received for investigation, it is possible to observe a bag of 20g needles, a bag is made up of four pieces, where one of the pieces it is possible to observe foreign matter at the height of the needle hub, therefore incident is confirmed.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Possible root cause is associated with use of a sponge (used as shock absorber) in the transfer guides after the vision chamber.This sponge accumulates silicone residue, which is used as a lubricant for the transfer guides in the production line, this sponge stains the base of the hub, generating a stain similar to the sample claimed by the customer.Manufacturing personnel have been notified of this incident to increase awareness of this matter.A project was initiated to reduce any foreign matter inside our products.

Event Description

It was reported that the bd needle 20ga 1-1/2in bil lax was dirty with machine grease.The following information was provided by the initial reporter, translated from spanish to english: 1 piece dirty.

• Brand Name: BD NEEDLE 20GA 1-1/2IN BIL LAX
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16054757
• MDR Text Key: 308447299
• Report Number: 9614033-2022-00119
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302350
• Device Lot Number: 2193787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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