MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 329605

Device Problem Inaccurate Information (4051)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 autoshield¿ duo safety pen needle experienced incorrect label information.The following information was provided by the initial reporter: physical barcode does not match the system.Customer has in his system the code: (b)(4).Physical box has code: (b)(4).

Manufacturer Narrative

Investigation: no samples were returned therefore the investigation was performed based on the photos provided.Three images pertaining to shelf carton information for lot# 1048278 were provided.The customer reported that the physical barcode does not match the system.The images were examined, and as per manufacturing the laser marking drawing for this cat number and the digits under the barcode are correct.The barcode from the dhr was also scanned and it scanned correctly.No evidence of manufacturing defect was observed.The alleged issue could not be confirmed based on the images provided alone.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that the bd autoshield¿ duo safety pen needle experienced incorrect label information.The following information was provided by the iniital reporter: physical barcode does not match the system.Customer has in his system the code: (b)(4).Physical box has code: (b)(4).

• Brand Name: BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13485854
• MDR Text Key: 289323873
• Report Number: 9616656-2022-00123
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K110703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 329605
• Device Lot Number: 1048278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• 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