MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD¿ BLUNT FILL NEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number 305243

Device Problem Contamination (1120)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

It was reported that the bd¿ blunt fill needle experienced foreign matter, contaminated.The following information was provided by the initial reporter, translated from portuguese to english: the material disposable needle 25x12 blunt tip ref.(b)(4), where it was identified that the item had a layer of white paint (plastic) on the rod and barrel.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary a batch history (dhr) analysis was performed, quality notifications were checked and no records potentially related to this defect were found for the lot and sub-lots consumed (assembled needle).It is possible to confirm the incident because the customer sent the photos, this is a process originating incident.Photos received by our quality team for investigation.Upon visual evaluation, white foreign matter is observed on the hub.The foreign substance is identified as epoxy, an adhesive used to join the cannula with the hub.This condition is part of the assembly process and when it occurs, the length of the injectable area is verified.Based on the teams investigation, possible root cause is associated with failure of the vision system.Adjustment made to the physical position of the clog camera and detection tool.

Event Description

It was reported that the bd¿ blunt fill needle experienced foreign matter, contaminated.The following information was provided by the initial reporter, translated from portuguese to english: the material disposable needle 25x12 blunt tip ref.(305243), where it was identified that the item had a layer of white paint (plastic) on the rod and barrel.

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17071675
• MDR Text Key: 316624336
• Report Number: 3003916417-2023-00123
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305243
• Device Lot Number: 2180603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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