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	07/08/2021
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
Catheter inserted on (b)(6) 2021, showed externalization of approximately 4cm and rupture with medication overflow on (b)(6) 2021, evidenced during dressing.
Additional Manufacturer Narrative
The 5f pro-picc was returned for evaluation.Visual inspection confirms the complaint as there is a lumen burst at the 2cm mark and another near the 12 cm mark.A guidewire was inserted from the distal end of both lumens and a great deal of dried blood and tissue was removed.The guidewire was then inserted into the white luer and advanced only to the point of the 2 cm burst.Forcing the advancement of the guidewire produced dried blood and tissue through the burst hole.The guidewire was then inserted into the purple luer and that advanced only to the 12 cm burst.Again forcing advancement of the guidewire produced dried blood and tissue through the burst hole.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specifications with no non-conformances or abnormalities.The inspection process includes a 100% leak test at the very end of the manufacture process that would have detected a leak or a weak spot if it existed at the time of manufacture.A definitive root cause cannot be determined but is not likely manufacture related.It is possible that flushing against resistance may have contributed to the lumen bursts.The instructions for use (ifu) contains the following information: occluded/partially occluded catheter - if resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Warning: do not flush against resistance.*if the lumen will neither aspirate nor flush, and it has been determined that the catheter is occluded with blood, follow institutional declotting procedure.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: 12210242
• Report Number: 2518902-2021-00048
• Device Sequence Number: 11722308
• Product Code: LJS
• UDI-Device Identifier: 00884908033250
• UDI-Public: 884908033250
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/30/2021

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: 03/03/2025
• Device Model Number: MR17035201
• Device Catalogue Number: MR17035201
• Device Lot Number: MPNH080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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: 69 YR
• Patient Weight: 110