TSCD NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-26 for TSCD NA manufactured by Terumo Medical Corp..

Event Text Entries

[136135] Repeated weld failures on new equipment. Device was put into service 4/5/99. First weld failures occurred on 4/9/1999. Intermittent problems w/ two other devices (same model), including wafer jams and failed welds leading to product loss. The first device was returned for servicing 7/99 and was placed back in service 10/5/99. Failed weld occurred on 10/5/99. Returned for servicing /repair.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017414
• MDR Report Key: 246619
• Date Received: 1999-10-26
• Date of Report: 1999-10-26
• Date Added to Maude: 1999-10-29
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TSCD
• Generic Name: STERILE TUBING WELDER
• Product Code: KSD
• Date Received: 1999-10-26
• Model Number: TSCD
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 238913
• Manufacturer: TERUMO MEDICAL CORP.
• Manufacturer Address: 2101 COTTONTAIL LN SOMERSET NJ 088731271 US

Device Sequence Number: 2

• Brand Name: TSCD
• Generic Name: STERILE TUBING WELDER
• Product Code: KSD
• Date Received: 1999-10-26
• Model Number: TSCD
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 238916
• Manufacturer: TERUMO MEDICAL CORP.
• Manufacturer Address: 2101 COTTONTAIL LN. SOMERSET NJ 088731271 US

Device Sequence Number: 3

• Brand Name: TSCD
• Generic Name: STERILE TUBING WELDER
• Product Code: KSD
• Date Received: 1999-10-26
• Model Number: TSCD
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 3
• Device Event Key: 238917
• Manufacturer: TERUMO MEDICAL CORP.
• Manufacturer Address: 2101 COTTONTAIL LN SOMERSET NJ 088731271 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-10-26