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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367300
Device Problems Microbial Contamination of Device (2303); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/03/2021
Event Type  malfunction  
Event Description
It was reported that while using bd vacutainer® multiple sample luer adapter a patient got infected and required medical intervention.The following information was provided by the initial reporter: "an infection.".
 
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that while using bd vacutainer® multiple sample luer adapter a patient got infected and required medical intervention.The following information was provided by the initial reporter: "an infection.".
 
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd vacutainer® multiple sample luer adapter had a short shots molding defect.The following information was provided by the initial reporter: "blood sample from peripheral kt.The blood was coming out in the vacutainer because of a twisted adapter.".
 
Manufacturer Narrative
Correction: b2: adverse type: product problem.B2: event attributed to: na.B5: describe event or problem: it was reported that bd vacutainer® multiple sample luer adapter had a short shots molding defect.The following information was provided by the initial reporter: "blood sample from peripheral kt.The blood was coming out in the vacutainer because of a twisted adapter." h2: type of reportable events: malfunction.H5: imdrf annex a grid: a040609.The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-14.H6: investigation summary : the sample of an unknown lot was evaluated by visual examination and a side pierced sleeve was observed with leakage in the holder of the device.No retention testing could be complete as the batch number is unknown and the scope of the investigation is limited.A device history review could not be completed as no batch number was provided.
 
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Brand Name
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12870991
MDR Text Key286248068
Report Number1024879-2021-00826
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K991088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367300
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
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) Required Intervention;
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