MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6F TRPL LMN PRO PICC; PRO-PICC CT

Model Number	MR17036302
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.When the investigation is complete a follow up report will be submitted.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
After the device was removed it was noted that the lumen was wrinkled and leaked.Issue was noticed outside the patient's body.Doctor said "it might be nurse frequently flushed heparin locked quite hard".
Additional Manufacturer Narrative
No device was returned for evaluation.Photographs were provided showing the burst in the lumen.The contract manufacturer conducted a review of the manufacture records for this device and found it was manufactured according to specification with no non-conformances or abnormalities.The device was implanted for 7 weeks prior to the incident and the physician reported it may have been related to user error.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.The instructions for use (ifu) contains the following warnings/precautions: *small syringes will generate excessive pressure and may damage the catheter.Ten (10)cc or larger syringes are recommended.*vigorously flush the pro-picc® ct catheter using a 10cc or larger syringe and sterile normal saline prior to and immediately following the completion of power injection studies.This will ensure the patency of the catheter and prevent damage to the catheter.Resistance to flushing may indicate partial or complete catheter occlusion.Do not proceed with power injection study until occlusion has been cleared.Warning: failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 6F TRPL LMN PRO PICC
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10239067
• Report Number: 2518902-2020-00026
• Device Sequence Number: 13656035
• Product Code: LJS
• UDI-Device Identifier: 00884908033465
• UDI-Public: 884908033465
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 05/28/2020
• Device Model Number: MR17036302
• Device Catalogue Number: MR17036302
• Device Lot Number: MNLH040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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