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

Catalog Number 305211

Device Problem Packaging Problem (3007)

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

Event Date 12/23/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1336506, medical device expiration date: 31-jan-2027, device manufacture date: 02-dec-2021.Medical device lot #: 1301735, medical device expiration date: 31-dec-2026, device manufacture date: 28-oct-2021.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 3 bd¿ blunt fill needles with filter from lot 1301735, and 24 needles from lot 1336506 had issues with damaged blister packs.The following information was provided by the initial reporter, translated from japanese: "torn blister pack.".

Manufacturer Narrative

The following fields were corrected due to additional information: device available for eval no returned to manufacturer on: investigation summary a device history record review was completed by our quality engineer team for provided material number 305211 and lot numbers 1301735 and 1336506.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

Event Description

It was reported that 3 bd¿ blunt fill needles with filter from lot 1301735, and 24 needles from lot 1336506 had issues with damaged blister packs.The following information was provided by the initial reporter, translated from japanese: "torn blister pack".

• Brand Name: BD¿ BLUNT FILL NEEDLE WITH FILTER
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16220152
• MDR Text Key: 308847956
• Report Number: 1911916-2023-00018
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: 00382903052110
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305211
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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