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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367746
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® buffered sodium citrate 0.4 ml /0.129m blood collection tubes found the tube was partially cracked.The following information was provided by the initial reporter.The customer stated: ¿it was hard to detach the tube from non-bd's (nipro's) holder; after detachment, the hcp found that the tube was partially cracked.".
 
Manufacturer Narrative
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 when using the bd vacutainer® buffered sodium citrate 0.4 ml /0.129m blood collection tubes found the tube was partially cracked.The following information was provided by the initial reporter.The customer stated: ¿it was hard to detach the tube from non-bd's (nipro's) holder; after detachment, the hcp found that the tube was partially cracked.".
 
Manufacturer Narrative
H.6.Investigation summary: bd received 1 photo from the customer in support of this complaint.A visual examination of photo was performed and revealed broken tubes.Bd was able to confirm the customer¿s indicated failure mode with the photo provided, however, the exact cause for the glass breakage could not be determined.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.H3 other text : see h.10.
 
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Brand Name
BD VACUTAINER® BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES
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 & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15529257
MDR Text Key303623252
Report Number1917413-2022-00616
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
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 10/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2023
Device Catalogue Number367746
Device Lot Number1350312
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2021
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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