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

Model Number	PFM2CT5DL
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was unable to be performed as the lot number was not provided.The risk management file was reviewed and includes this risk.Additional complaints have been rececived from this same customer.This appears to be a customer specific issue as no other complaints for the same or similar products have been received.The returned product was inspected and the cracked luer was observed.A different needle free valve was returned than the one provided.The possible cause of the issue could be the different needle free valve.It is recommended that the included needle free valve be used.Unable to determine the root cause.
Event or Problem Description
Picc luer hub cracked.There was no injury noted to the patient.The picc catheter was removed.At this point, a peripheral catheter was placed and we will continue to determine if central access is/is not necessary.

• Brand Name: PRMEPICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks; suite 150; carlsbad CA 92008
• MDR Report Key: 12512593
• Report Number: 2032582-2021-00008
• Device Sequence Number: 3913442
• Product Code: LJS
• UDI-Device Identifier: 00813623013735
• UDI-Public: 00813623013735
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K083873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFM2CT5DL
• Device Catalogue Number: PFM2CT5DL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/22/2021
• 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: Other