MAUDE Adverse Event Report: MEDCOMP 5FX55CM DUAL PRO PICC CT-BASIC; PRO-PICC CT

Model Number	MR17035201
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a final report will be submitted.
Event or Problem Description
Catheter ruptured 2mm beyond the 26cm mark.Reason for passage of the picc to antibiotic therapy (rocefin).
Additional Manufacturer Narrative
The contract manufacturer conducted an evaluation of the returned device.Visual inspection showed the solid purple catheter/tubing was wavy/twisted.At the 23cm mark a large kink was noted.Between the 23cm to 23.5cm mark a straight longitudinal slit was present.A cross section before and after the kinked/slit portion of the tubing was performed and measurements were taken where possible.Variation of the measurements may have been caused by handling or use of the catheter as it was implanted for 16 days.A review of the manufacture records for the lot reported showed the device was manufactured to specification.The root cause is most likely not due to the manufacture process.A definitive root cause cannot be determined.It is possible that the lumen being kinked or clotted may have contributed to the failure.The instructions for use contain the following.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.Failure to ensure patency of the catheter may result in catheter failure.

• Brand Name: 5FX55CM DUAL PRO PICC CT-BASIC
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8748421
• Report Number: 2518902-2019-00038
• Device Sequence Number: 16729039
• Product Code: LJS
• UDI-Device Identifier: 00884908033250
• UDI-Public: 884908033250
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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?: No
• Operator of Device: Other
• Device Expiration Date: 09/28/2021
• Device Model Number: MR17035201
• Device Catalogue Number: MR17035201
• Device Lot Number: MLPH920 S2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: 17 YR