MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SHARPS CONTAINERS

Catalog Number UNKNOWN

Device Problem Difficult to Remove (1528)

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

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr check due to unknown lot number.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

Event Description

It was reported that pen needles were hard to detach from unspecified bd sharps containers.The following information was provided by the initial reporter, "material no.Unknown, batch no.Unknown.It was reported that pen needles were hard to detach from the sharps container.(b)(4) was opened to record issues with pen needle.This record was opened by request of the aeg team to capture the sharps container issue in verbatim.No additional information about the complaint is available.Verbatim:she also reported she had 2 boxes of some needle that was hard to detach the pen needle from the sharp container.No information from one box.2nd box - lot# 8205943; expiration date-08-31-2023; item# 320109; sample discarded.Occurence-unknown.Incident date- unknown.Offered to send a voucher.".

• Brand Name: UNSPECIFIED BD SHARPS CONTAINERS
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8556554
• MDR Text Key: 147611445
• Report Number: 2243072-2019-00801
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other