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

Catalog Number 364975

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Injury (2348)

Event Date 12/09/2019

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 and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

Material no.364975, batch no.Unknown.It was reported that during use of the bd vacutainer® urine collection cups the patient poked her finger while using the cup.The following information was provided by the initial reporter: we had another incident at our (b)(4) laboratory today with the urine cup.The patient is a (b)(6) yr.Old, hispanic female who while using the cup poked her finger on the needle.According to our service representative the patient was given the proper collection instructions and asked not to touch that area of the cup.

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer facility 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 Description

Material no.364975 batch no.Unknown it was reported that during use of the bd vacutainer® urine collection cups the patient poked her finger while using the cup.The following information was provided by the initial reporter: we had another incident at our west covina laboratory today with the urine cup.The patient is a 77 yr.Old, hispanic female who while using the cup poked her finger on the needle.According to our service representative the patient was given the proper collection instructions and asked not to touch that area of the cup.

• 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: 9520886
• MDR Text Key: 178158315
• Report Number: 1917413-2019-02563
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR