MAUDE Adverse Event Report: PFM MEDICAL, INC. PRIMEPICC; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	PFM2CT5T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A documentation review was performed, and no discrepancies were identified with the finished goods lot 1711-007 or the picc raw material lot r1603-075.The picc was visually inspected upon return, and a gap was identified on the red luer.The gap is most likely a result of repeated over-tightening of luer lock connections (i.E.Syringes, caps, etc.) to the luer, as identified in the picc instructions for use (ls-00139-01).
Event or Problem Description
The picc was initially placed on (b)(6) 2018.Three days later the nurse was called by the infusion center to replace the picc due to leakage coming from the "red hub"(luer fitting).It was stated that the "red hub" was not cracked but rather described as having a hole.The picc was replaced.

• Brand Name: PRIMEPICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks way; suite 150; carlsbad CA 92008
• MDR Report Key: 7879161
• Report Number: 2032582-2018-00004
• Device Sequence Number: 182241
• Product Code: LJS
• UDI-Device Identifier: 00813623013780
• UDI-Public: 00813623013780
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: PFM2CT5T
• Device Catalogue Number: PFM2CT5T
• Device Lot Number: 1711-007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/14/2018
• 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: 65 YR