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

Model Number	PFM2CT4D
Medical Device Problem Codes	Crack (1135); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr review: a device history record (dhr) review was performed and no deviations were found.All inspection records are in order.No non-conformance record associated with lot# 2009-043 that could have contributed to the complaint.Review of recorded complaints on the last three years (2019-2021): 5 similar complaints but on different reference number (pfm2ct5dl, pfm2ct4d).Conclusion: the returned sample was visually inspected and the reported luer crack was confirmed.The reported competitor valve used during treatment was also visually inspected and observed to be smaller than the supplied needle-free valves from the kit.Luer fitting test was performed with the retained sample from the same lot using luer torque gauge and no deviations were found.The retained valve was also connected multiple times to the catheter without any issues.However, during testing of the returned valve sample, a scraping sound from the connection was noted at 8.78lbf-in.It is believed that the root cause could be attributed to the use of a different needle-free valve which may add more force than required during the connection.In addition, the ifu indicates that repeated over-tightening of the luer lock connection, syringes, and caps could lead to potential connector failure.For future procedures, it is recommended that only the supplied needle-free valve should be used to prevent any future occurrences.
Event or Problem Description
Picc was placed without issue.A few days later the line was leaking around a cap but thought to be a cap issue not a line issue, then the actual lumen of the catheter was noted to be cracked 4-5 days after placement.The caps we use are from icu medical, inc.Microclave clear neutral connecter.Patient was fine; new peripheral line was placed without issue after pfm picc line developed cracked luer.

• Brand Name: PRIMEPICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks; suite 150; carlsbad CA 92008
• Manufacturer (Section G): PFM MEDICAL, INC.; 1916 palomar oaks; suite 150; carlsbad CA 92008
• Manufacturer Contact: troy taylor ; 1916 palomar oaks; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 13336932
• Report Number: 2032582-2022-00002
• Device Sequence Number: 11742057
• Product Code: LJS
• UDI-Device Identifier: 00813623010185
• UDI-Public: 00813623010185
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K072391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/02/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: PFM2CT4D
• Device Catalogue Number: PFM2CT4D
• Device Lot Number: 2009-043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown