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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE GOLD BD HEMOGARD¿ CLOSURE

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BECTON, DICKINSON & CO., (BD) 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE GOLD BD HEMOGARD¿ CLOSURE Back to Search Results
Catalog Number 367986
Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2016
Event Type  malfunction  
Manufacturer Narrative
Results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for device malfunction with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure mode.
 
Event Description
It was reported that a 13x100 mm 5.0 ml bd vacutainer® plus plastic sst tube gold bd hemogard¿ closure needle would not properly insert to fill tube during draw.The yellow cap completely snapped off while in the vacutainer holder.When an attempt was made to remove the tube, it was noticed that the rubber stopper was not in the tube correctly.No serious injury or medical intervention was reported.
 
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Brand Name
13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE GOLD BD HEMOGARD¿ CLOSURE
Type of Device
VACUTAINER
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer (Section G)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7088366
MDR Text Key94522300
Report Number1024879-2017-00304
Device Sequence Number1
Product Code JKA
UDI-Device Identifier00382903679867
UDI-Public00382903679867
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other
Type of Report Initial
Report Date 11/25/2017
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 Date11/30/2016
Device Catalogue Number367986
Device Lot Number5316737
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/25/2016
Initial Date FDA Received12/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2015
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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