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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 366430
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2020
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported with the use of the bd vacutainer® serum blood collection tubes there was an adverse event without identified device or use problem.The following information was provided by the initial reporter.The customer stated "the adapter broke off inside the lumen.A user facility dialysis technician reported that the adapter broke off inside of the lumen.All attempts to remove it only broke it down even further." patient had to be sent to the er for evaluation of central venous catheter (cvc).Cvc was ultimately replaced by surgeon.
 
Manufacturer Narrative
H6 investigation: a review of the device history record was completed for this batch 0156058.All inspections were in compliance with requirements.There were no qns or ncmrs associated with this batch.Bd sumter received 10 bd luer adapter devices.The samples were subjected to a torque force test in order to test the hub strength.All 10 samples passed the test and met specification requirements.The minimum force required to break the hub as stated in vs50004 is 2.5lbs.The 10 samples tested with forces ranging from 2.95-5.16lbs.Based on the customer samples and investigation results, bd is unable to confirm the customer¿s reported failure mode of a broken device as we were unable to duplicate the reported failure mode.
 
Event Description
It was reported with the use of the bd vacutainer® serum blood collection tubes there was an adverse event without identified device or use problem.The following information was provided by the initial reporter.The customer stated "the adapter broke off inside the lumen.A user facility dialysis technician reported that the adapter broke off inside of the lumen.All attempts to remove it only broke it down even further." patient had to be sent to the er for evaluation of central venous catheter (cvc).Cvc was ultimately replaced by surgeon.
 
Event Description
It was reported with the use of the bd vacutainer® multiple sample luer adapter there was an adverse event without identified device or use problem.The following information was provided by the initial reporter.The customer stated "the adapter broke off inside the lumen.A user facility dialysis technician reported that the adapter broke off inside of the lumen.All attempts to remove it only broke it down even further." patient had to be sent to the er for evaluation of central venous catheter (cvc).Cvc was ultimately replaced by surgeon.
 
Manufacturer Narrative
The following fields have been corrected: b5.Describe event or problem: it was reported with the use of the bd vacutainer® multiple sample luer adapter there was an adverse event without identified device or use problem.The following information was provided by the initial reporter.The customer stated "the adapter broke off inside the lumen.A user facility dialysis technician reported that the adapter broke off inside of the lumen.All attempts to remove it only broke it down even further." patient had to be sent to the er for evaluation of central venous catheter (cvc).Cvc was ultimately replaced by surgeon.D1: medical device brand name: bd vacutainer® multiple sample luer adapter d2a: common device name: blood specimen collection device d2b: medical device type or (procode) : jka.D4 catalog #: 367290.D4.Medical device lot#: 0156058.D4 udi: (b)(4).G5.Pma/510k info: k991088.D4.Medical device expiration date: 31-may-2023.H4.Device manufacture date: 04-jun-2020.H6.Investigation summary: bd received ten (10) samples for investigation.The samples were evaluated by functional testing and the indicated failure mode for damaged with the incident lot was not observed as all product specifications were met.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.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
 
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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. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10907373
MDR Text Key218667296
Report Number1917413-2020-01185
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903672900
UDI-Public50382903672900
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2023
Device Model Number366430
Device Catalogue Number367290
Device Lot Number0156058
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/30/2020
Initial Date FDA Received11/26/2020
Supplement Dates Manufacturer Received01/21/2021
04/10/2023
Supplement Dates FDA Received01/21/2021
04/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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