MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COLLECTION CUPS; 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 03/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Material no.364975, batch no.Unknown.It was reported that after use of the bd vacutainer® urine collection cups a child put a used urine lid in their mouth.The child opened a sharps container that was in a phlebotomy room that contained only urine cup lids and put the lid into their mouth.No harm was proven but they went to a different facility for testing of the child.The following information was provided by the initial reporter: child opened a sharps container that was in a phlebotomy room.Sharps container contained only urine cup lids (#364975).No lot# available.Child put the lid into their mouth.

Manufacturer Narrative

Investigation: investigation summary: bd had not received samples from the customer facility for investigation.Photos were provided showing a container full of urine cups and an arrow pointing to the lid of a urine cup.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.Investigation conclusion: based on evaluation of the customer photos, a specific product issue was not observed.Root cause description: based on the investigation, a root cause could not be determined.Rationale: 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

Material no.364975, batch no.Unknown.It was reported that after use of the bd vacutainer® urine collection cups a child put a used urine lid in their mouth.The child opened a sharps container that was in a phlebotomy room that contained only urine cup lids and put the lid into their mouth.No harm was proven but they went to a different facility for testing of the child.The following information was provided by the initial reporter: child opened a sharps container that was in a phlebotomy room.Sharps container contained only urine cup lids (#364975).No lot# available.Child put the lid into their mouth.

• 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
• MDR Report Key: 8515484
• MDR Text Key: 142044632
• Report Number: 1917413-2019-01179
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

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: Other
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention