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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 1.5QT RED; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON SHARPS COLL 1.5QT RED; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 305487
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 07/21/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Oem manufacture: (b)(4).
 
Event Description
It was reported that sharps coll 1.5qt red lid won't close.The following information was provided by the initial reporter: "this is a lid issue for sharps collector 305487.The lid doesn't shut properly (opens soon).".
 
Event Description
It was reported that sharps coll 1.5qt red lid won't close.The following information was provided by the initial reporter: "this is a lid issue for sharps collector 305487.The lid doesn't shut properly (opens soon).".
 
Manufacturer Narrative
The following fields were updated with additional information: d.10.Device available for evaluation?: yes; returned to manufacturer on: 2020-09-04.H.3 device eval.By manufacturer: yes.H.6 investigation result codes: 213.Investigation method codes: 10.The following fields should be considered updated with additional information: investigation summary: bdj could not find any damages in the returned sample.When we shut the temporary lid, it was closed.We left it for a few minutes and it kept closed.  after that, we locked the temporary lid by mistake and could not observe it.Sample will be sent to vernon hills later.Cavity: 1075c-7.
 
Manufacturer Narrative
H.6.Investigation: dhr review process can¿t be performed because the lot number wasn¿t provided.A review of the ncmr¿s couldn¿t be performed because there was no lot number provided.According to information provided from customer a limited investigation was performed since there are no samples to evaluate this failure mode (temporary lid opened).Additional information is needed to determine the root cause of this issue as the temperature of environment where pieces are being in use/storage because they are plastic pieces (polypropylene), that information could help to determine if the form or function is being affected on the pieces).By other hand it¿s noticed that the temporary closure feature notified by customer it is not being evaluated during the in-process inspections performed by quality because isn¿t part of the customer specification requirement.According with previous complaints received throughout 2017 for the same issue, an engineering study was performed to evaluate the functionality on temporary closure feature including interaction between bases and lids after assembly.According to functional test results the failure mode reported from customer for the part number bdx-89990020 it wasn¿t observed, all samples were kept closed for the expected 30 seconds, additionally a pull test was performed over these samples even when it¿s not a customer specification requirement, the results showed a retention force to open the lids when the temporary closure is activated.The current material was evaluated within the process and the lid¿s kept closed during the temporary closure (this evaluation is performed after the pieces accomplishes the cure time of the plastic after molding process).H3 other text : see h.10.
 
Event Description
It was reported that sharps coll 1.5qt red lid won't close.The following information was provided by the initial reporter: "this is a lid issue for sharps collector 305487.The lid doesn't shut properly (opens soon).".
 
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Brand Name
SHARPS COLL 1.5QT RED
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10411591
MDR Text Key206106607
Report Number2243072-2020-01246
Device Sequence Number1
Product Code MMK
UDI-Device Identifier50382903054874
UDI-Public50382903054874
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305487
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2020
Date Manufacturer Received07/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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