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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 WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE

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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367354
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the tubes in the bd vacutainer® push button blood collection set with pre-attached holder were popping off the needle. No serious injury or medical intervention was reported.
 
Manufacturer Narrative
Bd received samples from the customer facility for investigation. The samples were tested and the customer's indicated failure mode for tube push off with the incident lot was not observed as all product specifications were met. A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product. Based on evaluation of the customer samples, the customer¿s indicated failure mode for tube push-off with the incident lot was not observed as all samples met the required specifications. Based on the investigation, a root cause could not be determined. The product was found to be in conformance and meet release specifications. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the tubes in the bd vacutainer push button blood collection set with pre-attached holder were popping off the needle. No serious injury or medical intervention was reported.
 
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Brand NameBD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Type of DeviceBLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key7704149
MDR Text Key114701688
Report Number1024879-2018-00381
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K011984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2020
Device Catalogue Number367354
Device Lot Number8012801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/19/2018 Patient Sequence Number: 1
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