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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE; SPECIMEN TRANSPORT AND STORAGE CONTAINER
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE; SPECIMEN TRANSPORT AND STORAGE CONTAINER Back to Search Results
Catalog Number 364992
Device Problems Short Fill (1575); Volume Accuracy Problem (1675)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that during use with a bd vacutainer® urine analysis preservative tube 5 vacutainers had a low draw.The following information was provided by the initial reporter: it is reported that customer is experiencing under filling.Additionally, on 2020-9-11 the customer provided the following additional information: the main complaint concerning your urine tubes is that there have been many in a certain lot number that would not fill to the minimum fill line.I gave those tubes to my supervisor.The culture tube filled completely.When the urinalysis tube was plunged, it did not fill.The chemistry tube was plunged and it filled completely.The ua tubes most always fill to the minimum line but rarely beyond that.
 
Manufacturer Narrative
H.6.Investigation summary: ten (10) customer samples were returned from the customer facility for evaluation.No photos were returned.Tubes were inspected with zero (0) visible defects.A draw test was performed at the manufacturing site on ten (10) samples.The ten (10) tubes were within specification limits.Upon evaluation of the customer returned samples, the customer¿s product issue was not observed.Ten (10) customer samples were tested with water and were within the specification limits.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.Bd has initiated further root cause investigation relating to the issue of underfill through a corrective and preventive action (capa)260774.H3 other text : see h.10.
 
Event Description
It was reported that during use with a bd vacutainer® urine analysis preservative tube 5 vacutainers had a low draw.The following information was provided by the initial reporter: it is reported that customer is experiencing under filling.Additionally, on 2020-9-11 the customer provided the following additional information: the main complaint concerning your urine tubes is that there have been many in a certain lot number that would not fill to the minimum fill line.I gave those tubes to my supervisor.The culture tube filled completely.When the urinalysis tube was plunged, it did not fill.The chemistry tube was plunged and it filled completely.The ua tubes most always fill to the minimum line but rarely beyond that.
 
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Brand Name
BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE
Type of Device
SPECIMEN TRANSPORT AND STORAGE CONTAINER
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
MDR Report Key10586708
MDR Text Key208942127
Report Number1917413-2020-00871
Device Sequence Number1
Product Code KDT
UDI-Device Identifier50382903649926
UDI-Public50382903649926
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2021
Device Catalogue Number364992
Device Lot Number9280801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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