MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER C&S TRANSFER STRAW KIT; URINE COLLECTION DEVICE

Catalog Number 364953

Device Problems Difficult to Insert (1316); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 08/05/2017

Event Type  malfunction  

Event Description

Staff have reported difficulty transferring urine from specimen cups (in patients with no foley) to the bd vacutainer tube using the c&s transfer straw kit.This has resulted to exposures and near misses with urine being spilled, which is particularly concerning when dealing with patients receiving chemotherapy.The straw end of the kit has to be held in the specimen cup while the vacutainer tube is pushed down onto the needle on the other end of the straw kit.Staffs have reported difficulty in getting the needle to penetrate the yellow rubber cap on the end of the vacutainer, resulting in jarring of the specimen cup and spillage of urine.

• Brand Name: BD VACUTAINER C&S TRANSFER STRAW KIT
• Type of Device: URINE COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr.; franklin lakes NJ 07417
• MDR Report Key: 6823261
• MDR Text Key: 83852806
• Report Number: 6823261
• Device Sequence Number: 1
• Product Code: OIE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 364953
• Device Lot Number: 7097784
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1