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

Catalog Number 364975

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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 that the lid on the bd vacutainer® urine collection cup was not leak-proof when properly secured, causing urine leakage that soiled that exterior of the cup and biohazard transport bag.Some samples were reportedly "refused" due to the excessive leakage, requiring patients to be recalled by the physician to recollect and delaying treatment.The following information was provided by the initial reporter: "the lids are not leak-proof even when properly sealed and screwed.The exterior of the cup is soiled and there is urine in the biohazard transport bag.Some samples are refused due to excessive leakage.The patients need to be recalled by the physician to repeat the sample.Test results and therefore treatment are delayed.".

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the lid on the bd vacutainer® urine collection cup was not leak-proof when properly secured, causing urine leakage that soiled that exterior of the cup and biohazard transport bag.Some samples were reportedly "refused" due to the excessive leakage, requiring patients to be recalled by the physician to recollect and delaying treatment.The following information was provided by the initial reporter: "the lids are not leak-proof even when properly sealed and screwed.The exterior of the cup is soiled and there is urine in the biohazard transport bag.Some samples are refused due to excessive leakage.The patients need to be recalled by the physician to repeat the sample.Test results and therefore treatment are delayed.".

• Brand Name: BD VACUTAINER® URINE COLLECTION CUP
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8453041
• MDR Text Key: 139959276
• Report Number: 1917413-2019-01048
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

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: Health Professional
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention