MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRA-FINE¿ III PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320179

Device Problem Inaccurate Information (4051)

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 50 bd ultra-fine¿ iii pen needles experienced incorrect label information, and a mix of product types in a pack.The following information was provided by the initial reporter: shelf carton and pouch has bd ultra-finetm iii brand name.However, tear drop label mentions bd micro-fine+, penta point technology.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 9253730; d4: medical device expiration date: 30-sep-2024; h4: device manufacture date: 01-sep-2020.D4: medical device lot #: 9148683; d4: medical device expiration date: 30-sep-2024; h4: device manufacture date: 01-sep-2020.H6: investigation summary no physical samples were received; the investigation was performed based on the photo provided.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.The complaint could not be confirmed hence the root cause is undetermined.H3 other text : see h10.

Event Description

It was reported that 50 bd ultra-fine¿ iii pen needles experienced incorrect label information, and a mix of product types in a pack.The following information was provided by the initial reporter: shelf carton and pouch has bd ultra-finetm iii brand name.However, tear drop label mentions bd micro-fine+, penta point technology.

• Brand Name: BD ULTRA-FINE¿ III PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13693685
• MDR Text Key: 287705077
• Report Number: 2243072-2022-00312
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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: Lay User/Patient
• Device Catalogue Number: 320179
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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