MAUDE Adverse Event Report: BECTON DICKINSON BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP; SHARPS CONTAINER

Catalog Number 305343

Device Problem Difficult to Open or Close (2921)

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

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd¿ sharps collection next gen 5.4qt red has a lid that does not shut.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7281921.Medical device expiration date: unknown.Device manufacture date: 10/19/2017.Medical device lot #: 7287914.Medical device expiration date: unknown.Device manufacture date: 10/26/2017.

Event Description

It was reported that a bd sharps collection next gen 5.4qt red has a lid that does not shut.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that a bd¿ sharps collection next gen 5.4qt red has a lid that does not shut.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned 10 boxes of lot#: 7281921 and #: 7287914.Bdj checked a total of 60 lids and confirmed all of the temporary lids kept closed over 10min.Dhr review: there are no issues reported related to temporary open/closure position, during the manufacturing process of any related lot number reported for this complaint.Ncmr(non conformance material report) review by part number: the ncmr¿s review to the last twelve months has been performed for the part number: 305343, the result was two ncmrs issued to same problem (lid didn¿t shut properly).1.Nc-rj001513 defect: functional failure in temporary closure / bdx-8990093 / 2011 cap open 8 quart / lot: 7093906 / qty3600 / wo bdx073638.2.Nc-rj001739 defect: functional failure in temporary closure / bdx-8990094 / subassembly open top / lot: 7206916 / w.O.Bdx078336 / qty 640.Investigation: according to this investigation this failure mode is already known since previous complaints were received for the same issue throughout 2017, for this reason a capa record#: ca-rj001797 was opened to perform the investigation as well to implement corrective actions.Due to the lot number was not provided from customer, it can¿t confirm if this issue arose after corrective action implementation.Corrective actions were full implemented for batches manufactured from 2018 on forward, in accordance to customer complaint records there is no complaints received from batches manufactured after corrective action.Root cause: slot reference dimension was found greater (loose) than drawing specification.Corrective actions: 1.Align steel as per drawing requirement.2.Create mold inserts to be replaced if needed, during preventive maintenance.Conclusion: based on this investigation this failure mode was caused due worn out on the mold, the corrective actions were implemented and evaluated as effective.

• Brand Name: BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7889850
• MDR Text Key: 120969911
• Report Number: 2243072-2018-01363
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 50382903053433
• UDI-Public: 50382903053433
• Combination Product (y/n): N
• PMA/PMN Number: K943134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305343
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other