MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5FX55CM DUAL PRO PICC CT-BASIC; PRO-PICC CT

Model Number	MR17035201
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Two days after insertion during first infusion session a leak was noted in the extension line.
Additional Manufacturer Narrative
The 5f pro picc was returned for evaluation.The condition of the returned device appears to be that of a device implanted much longer than 2 days.A great deal of adhesive was found on the hub and luer area of the device, some of which could not be removed.The extension lines are crimped, which is indicative of repeated clamping in the same location.It is at the crimp that the extension with the purple luer is leaking.The extension with the white luer leaks approximately 1.5cm from the hub.Under magnification it can be seen that both leaks are the result of a cracked extension tubing.Requests for the solution used in site care were not successful.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as the last step in the process.This test would have revealed the leak if it existed at the time of manufacture.Medcomp engineering reviewed the returned device.Their review revealed the extensions are delaminating and breaking at the hub juncture.The surface of the extensions has been modified by what appears to be some sort of "solvent".The extensions should be clear and smooth but are now cloudy and rough.There are marks on the extension as if it was clamped when exposed to the "solvent".The clamps remained long enough to distort the extension, or the "solvent" softened the extension allowing it to disfigure.The portions covered by the clamp appear to have been protected as they are smooth and shiny.The purple luer is discolored only on the outside.The inside is smooth with no discoloring.The extensions broke in an unusual manner.There are no signs of smooth cuts (scalpel) or elongation (ballooning, bursting, tensile forces).The break surface looks like the extension was ripped.A definitive root cause cannot be determined but is most likely caused by the solution used to clean the device.The instructions for use include the following catheter precaution."clamping of the tubing repeatedly in the same location will weaken tubing.Avoid clamping near the luer(s) and hub of the catheter." device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5FX55CM DUAL PRO PICC CT-BASIC
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11562461
• Report Number: 2518902-2021-00017
• Device Sequence Number: 17338775
• Product Code: LJS
• UDI-Device Identifier: 00884908033250
• UDI-Public: 884908033250
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/11/2021
• Device Model Number: MR17035201
• Device Catalogue Number: MR17035201
• Device Lot Number: MJJR270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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: Required Intervention
• Patient Age: 46 YR