MAUDE Adverse Event Report: BECTON DICKINSON BD¿ HUB CUTTER; SHARPS CONTAINER

Catalog Number 305307

Device Problem Failure to Cut (2587)

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

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(4).Medical device expiration date: n/a.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ hub cutter blades are not sharp.This occurred on 6 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: blades of bd hub cutter is less sharper than previous all.Unable to use after few hubs are cut.

Event Description

It was reported that bd¿ hub cutter blades are not sharp.This occurred on 6 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: blades of bd hub cutter is less sharper than previous all.Unable to use after few hubs are cut.

Manufacturer Narrative

H.6.Investigation summary: an available sample was provided by the customer to bd india.It was sent to vh and was contaminated.The sample was forwarded at the suppliers request from vernon hlls to meiban, shanghai but could not be evaluated by the manufacturer due to the type of contamination within the container, which could not be handled or decontaminated properly for any manual investigation with the sample.To date a final response has not been received from the supplier after several requests have been made.Per the supplier, they "have scheduled a meeting with the blade manufacturer in shanghai on the week of 21st oct to analyze the root caused".The supplier will initiate any capa required and has scheduled to meet their manufacturer to analyze the root cause for any necessary correction identified and required based on the related complaint.The complaint may be reopened if an evaluation is received from the supplier.The supplier corrective action may be referenced after investigation has completed to confirm the root cause in an additional closure for this complaint.The issue appears to be related to material failure or blade defective but was inconclusive.A device history review was not completed as no information was received from supplier related to the device.H3 other text : see section h.10.

• Brand Name: BD¿ HUB CUTTER
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8776706
• MDR Text Key: 150613961
• Report Number: 2243072-2019-01369
• Device Sequence Number: 1
• Product Code: MMK
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

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 Catalogue Number: 305307
• Device Lot Number: A18092201
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other