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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PLUS TUBE. CLEAR BD HEMOGARD¿ CLOSURE BLOOD COLLECTION TUBE

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BECTON, DICKINSON & CO. BD VACUTAINER® PLUS TUBE. CLEAR BD HEMOGARD¿ CLOSURE BLOOD COLLECTION TUBE Back to Search Results
Catalog Number 366703
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2015
Event Type  malfunction  
Manufacturer Narrative
Bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode for damaged rubber membrane on the tube with the incident lot was observed. Photos were also returned showing the reported defect. A review of the manufacturing records was completed for the incident lot and no issues were identified. Due to the severity ad occurrence rate, no capa will be opened. We will continue to monitor this defect for tracking and trending purposes.
 
Event Description
It was reported that 13x75 mm 3 ml bd vacutainer® plus tube. Clear bd hemogard¿ closure had a damaged rubber membrane on the tube. No injury or medical intervention.
 
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Brand NameBD VACUTAINER® PLUS TUBE. CLEAR BD HEMOGARD¿ CLOSURE
Type of DeviceBLOOD COLLECTION TUBE
Manufacturer (Section D)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7080965
MDR Text Key94797018
Report Number1917413-2017-00316
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial
Report Date 11/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2017
Device Catalogue Number366703
Device Lot Number5210569
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/04/2017 Patient Sequence Number: 1
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