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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER Back to Search Results
Model Number 366703
Device Problems Short Fill (1575); Volume Accuracy Problem (1675)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9004552, medical device expiration date: 2020-07-31, device manufacture date: 2019-01-04.Medical device lot #: 9095730, medical device expiration date: 2020-10-31, device manufacture date: 2019-04-05.Medical device lot #: 9158870, medical device expiration date: 2020-12-31, device manufacture date: 2019-06-07.Medical device lot #: 9280860, medical device expiration date: 2021-04-30, device manufacture date: 2019-10-07.Medical device lot #: 9344910, medical device expiration date: 2021-06-30, device manufacture date: 2019-12-10.Medical device lot #: 0133321, medical device expiration date: 2021-11-30, device manufacture date: 2020-05-12.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 while using bd vacutainer® no additive (z) tubes the tubes are underfilling.This occurred with six lots and there were 4 occasions with lot# 9158870.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the tubes are underfilling.He stated that the low volume vacuum situation is occurring at several sites, using both the bd vacutainer urine cup and the bd transfer straw.
 
Manufacturer Narrative
H.6.Investigation: bd received three customer samples from lot 9095730, three customer samples from lot 0072461, three customer samples from lot 9344910, one customer sample from lot 9158870, one customer sample from lot 0044096, one customer sample from lot 9004552, and three customer samples from lot 9280860 were returned from the customer facility for investigation.The samples were evaluated by both visual examination and functional testing and the indicated failure mode for draw volume (underfill) with the incident lot was not observed as all product specifications were met.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 issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.
 
Event Description
It was reported that while using bd vacutainer® no additive (z) tubes the tubes are underfilling.This occurred with six lots and there were 4 occasions with lot# 9158870.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the tubes are underfilling.He stated that the low volume vacuum situation is occurring at several sites, using both the bd vacutainer urine cup and the bd transfer straw.
 
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Brand Name
BD VACUTAINER NO ADDITIVE (Z) TUBES
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 Key11091201
MDR Text Key224688238
Report Number1917413-2020-01266
Device Sequence Number1
Product Code FMH
UDI-Device Identifier50382903667036
UDI-Public50382903667036
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number366703
Device Catalogue Number366703
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2020
Date Manufacturer Received01/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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