MAUDE Adverse Event Report: BD (SUZHOU) BD¿ PEN NEEDLES

Catalog Number 329497

Device Problem Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 12/07/2018

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 bd¿ pen needles were clogged during injection.

Manufacturer Narrative

Investigation summary: no actual sample was returned for evaluation.14 retained samples have been tested on thread function and clog test, all results meet the specification.Dhr of lot 7061488 was reviewed and no qn found.Manufacture records 7061488 were reviewed, no abnormality was found.Investigation conclusion: after customer visit and feedback from sales representative, it was determined that the incident was caused by customer since he didn¿t install pen needle into injection pen directly.This would cause needle clog to occur.Root cause description: based on the investigation, an exact root cause could not be determined.Bd was not able to duplicate or confirm the customers indicated failure mode.Rationale: as it was determined the incident was not related to a manufacturing process, no formal corrective action is required.

Event Description

It was reported that bd¿ pen needles were clogged during injection.

• Brand Name: BD¿ PEN NEEDLES
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 8203871
• MDR Text Key: 131716089
• Report Number: 3006948883-2018-00323
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 329497
• Device Lot Number: 7061488
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other