MAUDE Adverse Event Report: BD (SUZHOU) BD ULTRA-FINE¿ PEN NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 329490

Device Problem Leak/Splash (1354)

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

Event Date 10/28/2023

Event Type  malfunction  

Event Description

It was reported that the bd ultra-fine¿ pen needles was leaking.The following was translated from japanese to english: on october 28, 2023, due to diabetes, our hospital bought a disposable pen needle to inject insulin at home, and the needle leaked during the use at home, so we need to replace it with a new pen needle.

Manufacturer Narrative

E.1.Initial reporter phone #:(b)(6) h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.H3 other text : see h.10.

Event Description

It was reported that the bd ultra-fine¿ pen needles was leaking.The following was translated from japanese to english: on (b)(6) 2023 due to diabetes, our hospital bought a disposable pen needle to inject insulin at home, and the needle leaked during the use at home, so we need to replace it with a new pen needle.

• Brand Name: BD ULTRA-FINE¿ PEN NEEDLES
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18167173
• MDR Text Key: 328970570
• Report Number: 3014704491-2023-00742
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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 Catalogue Number: 329490
• Device Lot Number: 2062284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/19/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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