MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE

Catalog Number UNKNOWN

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It has been reported that one unspecified bd¿ pen needle has been found blocked during use.The following has been provided by the initial reporter: material no: unknown batch no: unknown.It was reported that the needle was blocked.Verbatim: needle blocked.

Event Description

It has been reported that one unspecified bd¿ pen needle has been found blocked during use.The following has been provided by the initial reporter: material no: unknown batch no: unknown it was reported that the needle was blocked verbatim: ¿ needle blocked.

Manufacturer Narrative

H.6.Investigation summary: customer returned one (1) used 31gx5mm bd pen needle without a cover or tear drop label attached.Customer reported needle blocked.The returned pen needle was examined, then tested for flow using a test pen injector: the pen needle was able to expel properly.Since no evidence of manufacturing defect was observed, the alleged issue could not be confirmed.Unable to perform a dhr review due to an unknown lot number.Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no capa is required at this time.H3 other text : see section h.10.

• Brand Name: UNSPECIFIED BD¿ PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9521722
• MDR Text Key: 177852577
• Report Number: 2243072-2019-02895
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other