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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE; BLOOD COLLECTION SET.

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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE; BLOOD COLLECTION SET. Back to Search Results
Catalog Number 367290
Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2016
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
Event Description
It was reported that bd vacutainer® luer-lok¿ access device gets stuck in fistula needles and break off when trying to twist loose.No serious injury or medical intervention reported.
 
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Brand Name
BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE
Type of Device
BLOOD COLLECTION SET.
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 Key7117071
MDR Text Key95079483
Report Number1024879-2017-00280
Device Sequence Number1
Product Code JKA
UDI-Device Identifier00382903672905
UDI-Public00382903672905
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367290
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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