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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 364314
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Event Description
It was reported when using the bd preset¿ arterial blood collection syringe there was insufficient blood flow through the device.The following information was provided by the initial reporter: translated to english.The patient went to the emergency department of our hospital.During arterial blood collection for the patient, it was found that the arterial blood collection device was bent without negative pressure.After replacement, blood collection could be normal.
 
Manufacturer Narrative
Investigation summary: bd had not received samples or photos for investigation.Therefore, 5 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to barrel damage or 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 modes barrel damage or insufficient blood flow.Bd was not able to identify a root cause for the indicated failure mode.
 
Manufacturer Narrative
Investigation summary: bd had not received samples or photos for investigation.Therefore, 5 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to barrel damage or 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 modes barrel damage or 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 preset¿ arterial blood collection syringe there was insufficient blood flow through the device.The following information was provided by the initial reporter: translated to english.The patient went to the emergency department of our hospital.During arterial blood collection for the patient, it was found that the arterial blood collection device was bent without negative pressure.After replacement, blood collection could be normal.
 
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Brand Name
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK 
Manufacturer (Section G)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK  
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12857546
MDR Text Key286120792
Report Number9617032-2021-01205
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K022426
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
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2022
Device Catalogue Number364314
Device Lot Number0330196
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2020
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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