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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 72L YELLOW AU; SHARPS CONTAINER
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BECTON DICKINSON SHARPS COLL 72L YELLOW AU; SHARPS CONTAINER Back to Search Results
Catalog Number 302406
Device Problems Break (1069); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Patient Involvement (2645)
Event Date 04/01/2020
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A correct lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.Medical device lot #: the customer provided lot # 9316912.This does not match the catalog number provided.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that sharps coll 72l yellow au lids are being locked before use.The following information was provided by the initial reporter: lids being locked before use.Staff advise they have recently been receiving these new containers in stock, with the lid slide already locked closed.In the attempts made to identify whether these were being delivered to onelink closed or were being closed somewhere between onelink and the receiving/ordering dhb dept, it has been highlighted that we have many new staff in onelink and inventory teams, and someone has followed the instructions on the lid, literally.Close door before transport.Clearly while inventory staff have not understood what these containers are for ¿ not unreasonable, these teams simply move stock as required ¿ the lids being locked has led to clinical staff using various methods to unlock the slides again so they could be filled, as required.They have been successful in unlocking them too¿ however this does create the potential that relocking them when full may not be as safe as it should be for transportation, as the mechanism may have been damaged.
 
Event Description
It was reported that sharps coll 72l yellow au lids are being locked before use.The following information was provided by the initial reporter: lids being locked before use.Staff advise they have recently been receiving these new containers in stock, with the lid slide already locked closed.In the attempts made to identify whether these were being delivered to onelink closed or were being closed somewhere between onelink and the receiving/ordering dhb dept, it has been highlighted that we have many new staff in onelink and inventory teams, and someone has followed the instructions on the lid, literally.Close door before transport.Clearly while inventory staff have not understood what these containers are for ¿ not unreasonable, these teams simply move stock as required ¿ the lids being locked has led to clinical staff using various methods to unlock the slides again so they could be filled, as required.They have been successful in unlocking them too¿ however this does create the potential that relocking them when full may not be as safe as it should be for transportation, as the mechanism may have been damaged.
 
Manufacturer Narrative
Investigation summary: a photo representation was provided for investigation.A review of the device history record (dhr) and non-conforming material report (ncmr) for the reported container was performed and no manufacturing or material defects were identified that could have caused or contributed to the reported incident.One of the photos showed a closed lid assembled with a container with nothing inside.Lids when provided directly from the manufacturer are tied and bound by a plastic strap in sets of five.Following the ifu the instructions are indicated for after use and when the collector is full once the contents have reached the fill line, that the door should be locked once ready for removal.Once the collector is locked this is a permanent closure and should not be reopened.It was noted that the lids have been handled by newer staff members and they may have misinterpreted the instruction for use.The root cause was determined to be improper training or misuse during assembly following the instructions for use.Bd will continue to monitor for any trends.H3 other text : see h.10.
 
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Brand Name
SHARPS COLL 72L YELLOW AU
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10011655
MDR Text Key189874027
Report Number2243072-2020-00702
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302406
Device Lot Number9316912
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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