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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367285
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/28/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed in sections as nipro is an oem manufacturing site.Bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for (b)(4) with the incident lot was observed.Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified.
 
Event or Problem Description
It was reported that bd vacutainer® safety-lok¿ blood collection set contained many black spots inside.
 
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Brand Name
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
Common Device Name
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7477094
Report Number2243072-2018-00567
Device Sequence Number806620
Product Code JKA
UDI-Device Identifier50382903672856
UDI-Public50382903672856
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K991088
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/25/2018
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 Expiration Date03/31/2019
Device Catalogue Number367285
Device Lot Number6C2911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/04/2017
Initial Report FDA Received Date05/01/2018
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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