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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE
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BD CARIBE LTD. BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 364880
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® blood transfer device holder with female luer adapter it was difficult to fill the tube.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "it was difficult to draw blood during blood transfer.".
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary bd had not received samples or photos for investigation.Therefore, 12 retention samples from bd inventory were evaluated by functional testing, each undergoing leakage and clogged cannula testing and no issues were observed relating to insufficient flow as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode insufficient blood flow.Bd was not able to identify a root cause for the indicated failure mode.
 
Event Description
It was reported when using the bd vacutainer® blood transfer device holder with female luer adapter it was difficult to fill the tube.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "it was difficult to draw blood during blood transfer.".
 
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Brand Name
BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer (Section G)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13862938
MDR Text Key288178261
Report Number2618282-2022-00009
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903648806
UDI-Public50382903648806
Combination Product (y/n)N
Reporter Country CodeJA
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 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number364880
Device Catalogue Number36488000
Device Lot Number1156553
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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