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 Exposure to Body Fluids (1745)

Event Date 02/05/2023

Event Type  Injury  

Manufacturer Narrative

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 during use with bd vacutainer® urine collection cups an injury occurred by the collection cup.The following information was provided by the initial reporter: customer report injury caused by the lid of the collection cup.No lot number provided.

Manufacturer Narrative

H.6.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.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

Event Description

It was reported that during use with bd vacutainer® urine collection cups an injury occurred by the collection cup.The following information was provided by the initial reporter: customer report injury caused by the lid of the collection cup.No lot number provided.

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16362463
• MDR Text Key: 309385092
• Report Number: 1917413-2023-00119
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other