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

Model Number 364956

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported the bd vacutainer® urine complete cup kit experienced under-fill or low draw.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated: "the urine c&s vacutainer included in kit would not fill up.No harm to patient.Potential harm to staff, with bio-hazard exposure.The spec tube in the urine kit were not filling up, used 2 kits to try and both kits the spec tubes were not filling.".

Manufacturer Narrative

H.6.Investigation: 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.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported the bd vacutainer® urine complete cup kit experienced under-fill or low draw.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated: "the urine c&s vacutainer included in kit would not fill up.No harm to patient.Potential harm to staff, with bio-hazard exposure.The spec tube in the urine kit were not filling up, used 2 kits to try and both kits the spec tubes were not filling.".

• Brand Name: BD VACUTAINER URINE COMPLETE CUP KIT
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11015060
• MDR Text Key: 221737877
• Report Number: 1917413-2020-01240
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: 50382903649568
• Combination Product (y/n): N
• PMA/PMN Number: K024240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 364956
• Device Catalogue Number: 364956
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1