MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number	8817278006
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2018
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, during the procedure, after the introducer needle was introduced into the patient's cavity, the guide wire was inserted into the introducer needle and was stuck after 9cm was reached.The guide wire could not be advanced or withdrawn from the introducer needle.The guide wire and introducer needle was removed together as a whole, and a new kit was opened to continue the procedure.The customer reported there was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted no abnormalities.Pmv performed functional testing, the guide wire was inserted and removed and reinserted into the tube without restriction.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A review of the dhr (device history record) indicates the product was 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.
Event or Problem Description
According to the reporter, during the procedure, after the introducer needle was introduced into the patient's cavity, the guide wire was inserted into the introducer needle and was stuck after 9cm was reached.The guide wire could not be advanced or withdrawn from the introducer needle.The guide wire and introducer needle were removed together as a whole unit, and the guide wire was still intact.A new kit was opened and used to continue the procedure.The customer reported no patient injury.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7450893
• Report Number: 3009211636-2018-00126
• Device Sequence Number: 106607
• Product Code: FJS
• UDI-Device Identifier: 10884521004252
• UDI-Public: 10884521004252
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K890288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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: 10/12/2019
• Device Model Number: 8817278006
• Device Catalogue Number: 8817278006
• Device Lot Number: 1430000146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1