Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2021
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® blood transfer device holder with female luer adapter the tube was unable to be filled completely.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "during the transfer of blood into the tube by using btd, air bubbles got mixed into the tube and the tube was underfilled.".
 
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd received 1 used and 2 unused samples and 1 photo for investigation.The photo was reviewed and the indicated failure mode for air bubbles with the incident lot was not observed as the photo only shows a used blood transfer device (btd) back in its packaging.No defects could be observed from the photo.Additionally, the customer samples were evaluated by functional testing, each used to transfer colored water into tubes, and no issues were observed relating to air bubbles as all samples met specifications.An additional 48 retention samples from bd inventory were evaluated by visual examination, 12 of which were also evaluated by functional leakage and torque testing and no issues were observed relating to air bubbles 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 air bubbles.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 the tube was unable to be filled completely.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "during the transfer of blood into the tube by using btd, air bubbles got mixed into the tube and the tube was underfilled.".
 
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd received 1 used and 2 unused samples and 1 photo for investigation.The photo was reviewed and the indicated failure mode for air bubbles with the incident lot was not observed as the photo only shows a used blood transfer device (btd) back in its packaging.No defects could be observed from the photo.Additionally, the customer samples were evaluated by functional testing, each used to transfer colored water into tubes, and no issues were observed relating to air bubbles as all samples met specifications.An additional 48 retention samples from bd inventory were evaluated by visual examination, 12 of which were also evaluated by functional leakage and torque testing and no issues were observed relating to air bubbles 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 air bubbles.Bd was not able to identify a root cause for the indicated failure mode.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12855068
MDR Text Key286124125
Report Number2618282-2021-00069
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
Report Date 11/03/2021
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 Model Number364880
Device Catalogue Number364880
Device Lot Number1116424
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2021
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
-
-