MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	8888231330
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/30/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intraoperatively, provider inserted a 30cm catheter when he thought it was a 20cm, thus penetrating patients heart.It was stated that the catheter was not repaired, there was no leak, no cleaning agents was used and there was no luer adapter issue.It was reported that patient ended up expiring but cause was unknown as patient had multiple gunshot wounds.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intraoperatively, provider inserted a 30cm catheter when he thought it was a 20cm, thus penetrating patients heart.It was reported that there was patient harm at the cavo-atrial junction and patient had symptoms of hemodynamically unstable and was corrected via bedside surgery, patient improved after correction.It was stated that the catheter was not repaired, there was no leak, no cleaning agents was used and there was no luer adapter issue.It was reported that patient ended up expiring due to the injuries sustained due to the gunshot wounds.

• Brand Name: MAHURKAR ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8733473
• Report Number: 3009211636-2019-00144
• Device Sequence Number: 19294156
• Product Code: NIE
• UDI-Device Identifier: 10884521127517
• UDI-Public: 10884521127517
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K120674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888231330
• Device Catalogue Number: 8888231330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 48 YR
• Patient Weight: 117