MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERMCATH; CATHETER, SUBCLAVIAN

Model Number 8817748001

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer states the patient came in 6 days after placement due to bleeding.After inspection it was noticed there was a hole in the shaft below the cuff.The catheter was removed and replaced and there was no harm to the patient.

• Brand Name: PERMCATH
• Type of Device: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: diane matheus ; 15 hampshire street; mansfield, MA 02048 ; 5085421480
• MDR Report Key: 6800102
• MDR Text Key: 82896898
• Report Number: 3009211636-2017-05264
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 20884521009865
• UDI-Public: 20884521009865
• Combination Product (y/n): N
• Reporter Country Code: SU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 1704600121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2017
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1