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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PLASMA PREPARATION TUBE PPT¿ BLOOD COLLECTION TUBE

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BECTON, DICKINSON & CO. BD VACUTAINER® PLASMA PREPARATION TUBE PPT¿ BLOOD COLLECTION TUBE Back to Search Results
Catalog Number 362761
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2017
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 missing label with the incident lot was observed. A review of the manufacturing records was completed for the incident lot and no issues were identified. Conclusion: after investigation, there were no manufacturing related notifications that would account for this defect. The exact root cause is unknown.
 
Event Description
It was reported that bd vacutainer® plasma preparation tube (ppt¿) was missing a label. No serious injury, no medical interventions. Problem was noticed before use.
 
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Brand NameBD VACUTAINER® PLASMA PREPARATION TUBE PPT¿
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 Key7075927
MDR Text Key94214840
Report Number1917413-2017-00504
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K911731
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 11/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2017
Device Catalogue Number362761
Device Lot Number6245977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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: 12/01/2017 Patient Sequence Number: 1
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