MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTORS HOME; SHARPS CONTAINER

Catalog Number	323487
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In this mdr, bd (b)(6) in (b)(6) has been listed as premium plastic solution is an oem manufacturing site.Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported after use of the bd¿ sharps collectors home the spouse of consumer received a needle stick.She states ¿when picking up the home sharps container she was poked by a needle that had punctured through the wall of the container, consumer is seeking medical attention and plans to get a tetanus shot,.¿ there was no report of injury or medical intervention.
Additional Manufacturer Narrative
No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.As per qe, a dhr review of the risk management file for this issue shows that the risk for this issue is low.Also, for this product, the sharps collector is puncture resistant, not puncture proof.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.

• Brand Name: BD¿ SHARPS COLLECTORS HOME
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7353673
• Report Number: 2243072-2018-00148
• Device Sequence Number: 1741088
• Product Code: FMI
• UDI-Device Identifier: 00382903234875
• UDI-Public: 00382903234875
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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
• Operator of Device: Patient Family Member or Friend
• Device Catalogue Number: 323487
• Device Lot Number: 7277001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention