MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. WHIN®; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 471720

Device Problem Material Perforation (2205)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/25/2017

Event Type  malfunction  

Event Description

In central supply, a whin infusion set with an enclosed needle perforated the packaging and nurse was stuck in her finger.

• Brand Name: WHIN®
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6543659
• MDR Text Key: 74426833
• Report Number: 6543659
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 471720
• Device Catalogue Number: 471720
• Device Lot Number: 61218097
• Other Device ID Number: 20 GA 1 INCH
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other
• Patient Age: 11111 YR
• Patient Weight: 111