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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE TRANSFER STRAW; TRANSPORT CULTURE MEDIUM
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE TRANSFER STRAW; TRANSPORT CULTURE MEDIUM Back to Search Results
Catalog Number 364940
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.
 
Event Description
It was reported that bd vacutainer® urine transfer straw was difficult to attach to the tube.The following information was provided by the initial reporter: "urine straw -> difficult to push the urine tube in the straw.Urine straw -> difficult to push the urine tube in the straw.You have to push very hard.Is very difficult the customer told me.".
 
Event Description
It was reported that bd vacutainer® urine transfer straw was difficult to attach to the tube.The following information was provided by the initial reporter: "urine straw -> difficult to push the urine tube in the straw.Urine straw -> difficult to push the urine tube in the straw.You have to push very hard.Is very difficult the customer told me".
 
Manufacturer Narrative
Additional information d.10 samples received: (b)(6) 2020 h.6 investigation summary : bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for other (difficult to push the urine tube in the straw) with the incident lot was not observed as all product specifications were met.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-conformances during manufacturing of the product.
 
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Brand Name
BD VACUTAINER® URINE TRANSFER STRAW
Type of Device
TRANSPORT CULTURE MEDIUM
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
MDR Report Key9869156
MDR Text Key186703018
Report Number1917413-2020-00326
Device Sequence Number1
Product Code JSM
Combination Product (y/n)N
PMA/PMN Number
N/A
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 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number364940
Device Lot Number9256455
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2020
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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