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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET Back to Search Results
Catalog Number 367338
Device Problem Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2017
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for holes in the tubing with the incident lot was observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for holes in the tubing was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd has initiated a capa to document further investigation and root cause(s) of this product issue.Conclusion: bd was able to confirm the customer's indicated failure mode.Based on the investigation, the most likely root cause has been identified for tubing leakage, and capa (b)(4) has been initiated to document the investigation and root cause analysis of the reported incidents.Refer to the referenced capa for related corrective and preventive actions.
 
Event Description
It was reported that the tubing in the bd vacutainer® push button blood collection set was pierced.No serious injury or medical intervention.
 
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Brand Name
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
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 Key7088648
MDR Text Key94968743
Report Number1024879-2017-00937
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903673389
UDI-Public50382903673389
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K030573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/25/2017
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
Device Operator Other
Device Expiration Date08/31/2018
Device Catalogue Number367338
Device Lot Number6244603
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/02/2017
Initial Date FDA Received12/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2016
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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