MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 7.6L HONG KONG 24; SHARPS CONTAINER

Catalog Number 5460H-ZKP

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is an unspecified oem manufacturing site, as the lot # is unknown.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.The reported lot # [oa801] was not found for the reported catalog # [5460h-zkp].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that a needle pierced through the bottom of the sharps coll 7.6l hong kong 24 during use.The following information was provided by the initial reporter: 'complaint from (b)(6) hospital.The user complained that a needle was found penetrated the bottom of the sharp box.".

Manufacturer Narrative

H6: investigation summary sample pictures were provided for further investigation.An evaluation of the pictures confirmed the reported failure mode.A needle is visibly protruding through the bottom of the collector.A complaint history review was performed and no other complaint history for this product or any other related complaints was found for the container.A dhr review was not possible as no bd manufacturing supplier for this product was identified and we are not able to confirm the current manufacturer for this product at this time.Should a supplier confirm the manufacturing an additional closure letter may be provided with any additional results of the investigation.Based on the reported failure mode, the most likely source for this complaint was container contents and possible overfilling.This fill line cannot be identified in the pictures provided.A dashed line across the top of the container label will identify the fill limits and capacity for the collector contents.Also, please note, all collectors are only puncture resistant and are not puncture proof.Any harder outside force, or mishandling of the container, like reuse, or overfilling will compromise the effective resistance of the product, and a needle puncture can possibly occur.

Event Description

It was reported that a needle pierced through the bottom of the sharps coll 7.6l hong kong 24 during use.The following information was provided by the initial reporter: 'complaint from gleneagles hong kong hospital.The user complained that a needle was found penetrated the bottom of the sharp box.".

• Brand Name: SHARPS COLL 7.6L HONG KONG 24
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10423655
• MDR Text Key: 204071792
• Report Number: 2243072-2020-01275
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5460H-ZKP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 12/12/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other