MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINE COMPLETE CUP KIT; TRANSPORT CULTURE MEDIUM

Model Number	364956
Medical Device Problem Codes	Leak/Splash (1354); Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported with the use of the bd vacutainer® urine complete cup kit there was under-fill or low draw of a tube with blood and sample leakage.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated there was leakage when using urine cup as well as underfilling of c&s tube included in kit.Reporter tried two different cups and when trying to insert urine into specimen tubes there was a malfunction and urine was not dispensed into tubes from cup.Minimal urine in yellow tube, no urine in gray tube this happened two times.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.
Event or Problem Description
It was reported with the use of the bd vacutainer® urine complete cup kit there was under-fill or low draw of a tube with blood and sample leakage.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated there was leakage when using urine cup as well as underfilling of c&s tube included in kit.Reporter tried two different cups and when trying to insert urine into specimen tubes there was a malfunction and urine was not dispensed into tubes from cup.Minimal urine in yellow tube, no urine in gray tube this happened two times.

• Brand Name: BD VACUTAINER URINE COMPLETE CUP KIT
• Common Device Name: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10865194
• Report Number: 1917413-2020-01163
• Device Sequence Number: 14193765
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: 50382903649568
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2021
• Device Model Number: 364956
• Device Catalogue Number: 364956
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1