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 4 bd¿ blunt fill needles with filter from lot 1301735, and 1 needle from lot 1336506 had issues packaging seal failure.The following information was provided by the initial reporter, translated from japanese: "seal failure.".

Manufacturer Narrative

The following fields were corrected due to additional information: d10: device available for eval no.D10: returned to manufacturer on: na.H6: investigation summary it was reported there were multiple defects with units received.To aid in the investigation, two photos were provided for evaluation of damaged shields by our quality team.One photo shows a plastic bag with the number 1301735 with six packaging blisters next to it.The other photo shows a magnification of the bottom part of a needle assembly with the shield damaged.No other defects or imperfections were observed.A device history record review was completed for provided material number 305211, lot numbers 1301735 and 1336506.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be offered.

Event Description

It was reported that 4 bd¿ blunt fill needles with filter from lot 1301735, and 1 needle from lot 1336506 had issues packaging seal failure.The following information was provided by the initial reporter, translated from japanese: "seal failure".

• 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: 16220155
• MDR Text Key: 308664794
• Report Number: 1911916-2023-00017
• 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