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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 & STORAGE CONTAINER

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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT & STORAGE CONTAINER Back to Search Results
Catalog Number 366703
Device Problem Short Fill (1575)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd vacutainer® no additive (z) tubes lost vacuum.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.366703, batch no.9036729 it was reported that two consecutive waste tubes lost vacuum.Regarding the waste tube that was faulty¿ i have collected that information to report below.Two consecutive waste tubes losing vacuum.Switched to lavender tube and 3ml waste collected with vacutainer.Another used to get full h&h.
 
Manufacturer Narrative
The following fields have been updated with additional information: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 9036729.D.4.Medical device expiration date: 2020-08-31.H.4.Device manufacture date: 2019-02-05.D.4.Medical device lot #: 9036728.D.4.Medical device expiration date: 2020-08-31.H.4.Device manufacture date: 2019-02-05.
 
Event Description
It was reported that bd vacutainer® no additive (z) tubes lost vacuum.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.366703 batch no.9036729, 9036728.It was reported that two consecutive waste tubes lost vacuum.Regarding the waste tube that was faulty¿ i have collected that information to report below.Two consecutive waste tubes losing vacuum.Switched to lavender tube and 3ml waste collected with vacutainer.Another used to get full h&h.
 
Manufacturer Narrative
Investigation: bd received samples from the customer facility for investigation.The samples were draw tested and the customer's indicated failure mode for lost vacuum with the incident lot was not observed.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.Even though the customer's indicated failure mode was not observed with the samples provided, bd has initiated further investigation relating to this issue through capa#260774.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.
 
Event Description
It was reported that bd vacutainer® no additive (z) tubes lost vacuum.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.366703 batch no.9036729, 9036728 it was reported that two consecutive waste tubes lost vacuum.Regarding the waste tube that was faulty¿ i have collected that information to report below.Two consecutive waste tubes losing vacuum.Switched to lavender tube and 3ml waste collected with vacutainer.Another used to get full h&h.
 
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Brand Name
BD VACUTAINER® NO ADDITIVE (Z) TUBES
Type of Device
SPECIMEN TRANSPORT & STORAGE CONTAINER
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
MDR Report Key8932568
MDR Text Key155854326
Report Number1917413-2019-01979
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 foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2020
Device Catalogue Number366703
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2019
Initial Date Manufacturer Received 07/31/2019
Initial Date FDA Received08/26/2019
Supplement Dates Manufacturer Received07/31/2019
07/31/2019
Supplement Dates FDA Received09/06/2019
09/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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