MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COLLECTION CUPS; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364975

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  malfunction  

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.

Event Description

It was reported when using the bd vacutainer® urine collection cups, the device experienced sample leakage and sterility issues.The following information was provided by the initial reporter.The customer stated: it was detected a failure to cap the urine sample collection container.In this case, it presented a leakage, sample was lost and there was a contamination of sen.The device has been discarded and new samples were required.

Manufacturer Narrative

H.6.Investigation: no customer samples and 5 photos were returned by the customer in support of this complaint.Lot number is unknown.The photos were evaluated and show a cup in a bag with urine in the bag and cup.Bd was able to confirm the customer¿s indicated failure mode with the photos provided; however, the lids do not provide a liquid tight barrier and are not meant to be on their side or sent through a pneumatic system.The device history records could not be reviewed as the lot number is unknown.

Event Description

It was reported when using the bd vacutainer® urine collection cups, the device experienced sample leakage and sterility issues.The following information was provided by the initial reporter.The customer stated: it was detected a failure to cap the urine sample collection container.In this case, it presented a leakage, sample was lost and there was a contamination of sen.The device has been discarded and new samples were required.

• Brand Name: BD VACUTAINER® URINE COLLECTION CUPS
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14115496
• MDR Text Key: 289324213
• Report Number: 1917413-2022-00197
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female