MAUDE Adverse Event Report: MEDCOMP 6FX60CM TRPL PRO-PICC; PRO-PICC CT

Model Number	MR17036306MB
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.
Event or Problem Description
When flushing picc immediately after placement noticed leaking and hole at site where picc joins hub.
Additional Manufacturer Narrative
Received a 6f pro- picc for evaluation.The device was forwarded to the contract manufacturer for evaluation and investigation.A visual inspection reveals the catheter to be trimmed at the 44cm mark.There is no visible damage to the luers, clamps, extension, or hub.The lumen is partially separated from the hub.The end of the lumen which remains inside the hub appears to have been pulled.Inspection records, device history records and inspection of the returned sample were performed.Upon evaluation for lumen patency the part of the lumen that remained inside the hub appeared to have been pulled.100% leak testing was performed on the catheter sub-assembly prior to release.It was determined that the damage observed was not related to the manufacturing process.No corrective/preventative actions were required.A review of the risk analysis found that this failure, catheter leaks, had been addressed and no new risks were identified.

• Brand Name: 6FX60CM TRPL PRO-PICC
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6636378
• Report Number: 2518902-2017-00022
• Device Sequence Number: 90916
• Product Code: LJS
• UDI-Device Identifier: 00884908083378
• UDI-Public: 884908083378
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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: Other
• Device Expiration Date: 11/30/2017
• Device Model Number: MR17036306MB
• Device Catalogue Number: MR17036306MB
• Device Lot Number: MCCC820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR