MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN CHEMOSITE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	120027
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device was implanted.The patient had undergone x-ray to check the status of the product.They found that the product was falling off.The surgeon found the tube was broken and removed the device.The surgeon implanted a new one.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d6, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) received one photograph of one device opened by the account without the packaging.Visual inspection found the photograph to be of poor quality (hazy, out of focus).The photograph consists of some tubing and a port and adapter, all disassembled.Because of the poor quality, pmv was unable to determine any discrepancies.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CHEMOSITE
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9608702
• Report Number: 1219930-2020-00337
• Device Sequence Number: 547304
• Product Code: LJT
• UDI-Device Identifier: 10884521099388
• UDI-Public: 10884521099388
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K952748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 120027
• Device Catalogue Number: 120027
• Device Lot Number: N4G1531X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR