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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBE EXTENDER; BLOOD SPECIMEN COLLECTION DEVICE
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BD CARIBE LTD. BD MICROTAINER® TUBE EXTENDER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 365976
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Information (3190)
Date of Event 03/11/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.(b)(6).Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
 
Event or Problem Description
It was reported that bd microtainer® tube extender had a stopper pull out of tube when in an analyzer.
 
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Brand Name
BD MICROTAINER® TUBE EXTENDER
Common Device Name
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
MDR Report Key7494348
Report Number2618282-2018-00553
Device Sequence Number1768919
Product Code JKA
UDI-Device Identifier50382903659765
UDI-Public50382903659765
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K931368
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/27/2018
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
Operator of Device Other
Device Catalogue Number365976
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/11/2015
Initial Report FDA Received Date05/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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