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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 17L YELLOW; SHARPS COLLECTOR

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BECTON DICKINSON SHARPS COLL 17L YELLOW; SHARPS COLLECTOR Back to Search Results
Catalog Number 303209
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2020
Event Type  malfunction  
Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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 expiration date: na.Investigation summary: retain samples of the two noted production batches were reviewed and found to conform to cap application and pull off forces.This indicates no concern during the manufacture of the container from a dimensional point of view.It is most probably (without further relevant information) that the cap/closure was not effectively applied by the line operator during the secondary application process causing it to "detach" as advised.The application process has been reviewed and found to be effective in its application.Random audit of the process and feedback has been sought for any concerns that may be identified that may require correction.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance's during manufacturing of the product.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned, and retained samples were found to conform to specification.Root cause description: supplier (b)(4).Rationale: based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that 2 sharps coll 17l yellow lids detached from their collectors before use.The following information was provided by the initial reporter: "detaching lids.".
 
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Brand Name
SHARPS COLL 17L YELLOW
Type of Device
SHARPS COLLECTOR
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10052330
MDR Text Key195266682
Report Number2243072-2020-00764
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/23/2020
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 Number303209
Device Lot Number19197006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/23/2020
Initial Date FDA Received05/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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