MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 8830415001

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Skin Irritation (2076); Unintended Radiation Exposure (4565)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, on (b)(6) 2017, after a procedure with the catheter, the patient incurred a cutaneous lesion due to incompatible malleability of the product.The patient is alive with noted injury.

Manufacturer Narrative

Additional information: rfnr (changed to customer discarded), fdp codes and rfr was updated and changed.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, after catheter implantation, the patient incurred a cutaneous lesion due to incompatible malleability of the device.It was said that it was necessary to perform an x-ray to check positioning because access was being lost due to its malleability.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: jacqueline st. pierre ; 15 hampshire street; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7021850
• MDR Text Key: 91798845
• Report Number: 3009211636-2017-05344
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20884521005157
• UDI-Public: 20884521005157
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2021
• Device Model Number: 8830415001
• Device Catalogue Number: 8830415001
• Device Lot Number: 1621000154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 02/09/2021
• Date Device Manufactured: 07/29/2016
• 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