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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD¿ TRAY SHARPS¿ COLLECTOR WITH FUNNEL ENTRY; SHARPS COLLECTOR
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BECTON DICKINSON BD¿ TRAY SHARPS¿ COLLECTOR WITH FUNNEL ENTRY; SHARPS COLLECTOR Back to Search Results
Catalog Number 300450
Device Problems Detachment Of Device Component (1104); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.The manufacturing location for this product is flextronics.This site is an oem manufacturing site.
 
Event Description
It was reported by the pharmacist that the bd¿ tray sharps¿ collector with funnel entry have had reported lids re-open after being sealed when they are accidentally knocked over.No reports of serious injury or medical intervention noted.
 
Event Description
It was reported by the pharmacist that the bd¿ tray sharps¿ collector with funnel entry have had reported lids re-open after being sealed when they are accidentally knocked over.No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.
 
Manufacturer Narrative
Investigation summary: no photos or samples were received.A review of six dhrs was performed as part of this investigation; three dhr¿s before (6337926, 7034928, 7036919) and three after (7059925, 7075931, 7091903) of the lot number 7057963 reported under this complaint.The result did not reveal any issues during the manufacturing process.Additionally, ten samples from the current process were taken and assembled to rule out issues between the assembly of base and lid, during the evaluation no issues were found.Risk assessment (b)(4).According with this result a capa record should be open due to quantity of recurrences; however, the non-conformance can¿t be confirmed due to lack of evidence (samples/pictures).Based on information provided it was not possible determine the root cause like a failure mode related to the manufacturing process since there is no enough information like a picture or sample to confirm the non-conformance reported under this complaint.All the complaint information was captured for tracking and trending purposes, if additional information can be provided then a new complaint record will be open to perform a new investigation path.A corrective action is not required based on the results of the investigation.Trending for the reported issue will continue to be tracked and monitored.
 
Event Description
It was reported by the pharmacist that the bd¿ tray sharps¿ collector with funnel entry have had reported lids re-open after being sealed when they are accidentally knocked over.No reports of serious injury or medical intervention noted.
 
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Brand Name
BD¿ TRAY SHARPS¿ COLLECTOR WITH FUNNEL ENTRY
Type of Device
SHARPS COLLECTOR
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7375236
MDR Text Key103703862
Report Number2243072-2018-00171
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Pharmacist
Device Catalogue Number300450
Device Lot Number7057963
Date Manufacturer Received03/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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