MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ BLUNT FILL NEEDLE WITH FILTER; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number 302011

Device Problem Packaging Problem (3007)

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

Event Date 01/03/2023

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 a green-capped needle of a different size was found in the unit pack of black-capped bd¿ blunt fill needles with filter before use.The following information was provided by the initial reporter: "on (b)(6) 2023, during the separation of the needles.In a group of 5 unit packs of black needles, one of the needles is green.The size of the needles was different.".

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the 5 photos submitted for evaluation.The reported issue of mixed products / lots was confirmed upon inspection of the photos.In the photos it can be observed that one 21g needle (green hub) was inside 22g 1-1/4in blister packaging.During production of the batch involved in this complaint a batch of the 21g needle was produced on the same manufacturing machine.The probable cause could be the assembled 21g needle from previous batch might be left in the blind spot corner of the needle hopper bin after the elevator station.The product technicians would have been unable to see the 21g needle within the 22g needle production.There are blind spot mirrors installed at the corner for a clear view to ensure all left over parts are cleared, however there are still some areas that are still not easily visible.Actions are being taken to prevent the reoccurrence of this issue.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

Event Description

It was reported that a green-capped needle of a different size was found in the unit pack of black-capped bd¿ blunt fill needles with filter before use.The following information was provided by the initial reporter: "on (b)(6) 2023, during the separation of the needles.In a group of 5 unit packs of black needles, one of the needles is green.The size of the needles was different.".

• Brand Name: BD¿ BLUNT FILL NEEDLE WITH FILTER
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16244965
• MDR Text Key: 308949565
• Report Number: 8041187-2023-00017
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302011
• Device Lot Number: 2110439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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