MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE¿+ PRO PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320559

Device Problem Break (1069)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the non-patient end of 7 bd micro-fine¿+ pro pen needles were broken.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from japanese: "when checking the product, i saw the needle npe broken.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 10-jan-2023.H6: investigation summary: wo open 32g x 4mm pen needle samples and three photos were returned from an unknown lot.No., cat.No.320559.Visual examination was carried out on the returned samples and photos and a bent non patient end of cannula was observed on one sample due to the condition this sample was returned no clog test could be carried out.A clog test was carried out on the remaining sample and no issues were observed.No dhr review can be carried out as lot number is unknown.As the samples returned were open it is not possible to confirm this defect to be manufacturing related.

Event Description

It was reported that the non-patient end of 7 bd micro-fine¿+ pro pen needles were broken.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from japanese: "when checking the product, i saw the needle npe broken.".

• Brand Name: BD MICRO-FINE¿+ PRO 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: 16080731
• MDR Text Key: 308476910
• Report Number: 9616656-2022-01438
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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