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

Model Number	PFM2CT5DL
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the lot number was unknown, a device history record (dhr) review was not able to be performed.However, visual inspection of the returned product was conducted and the cracked was observed.Reportedly, the nurse used forceps to tighten the hub connection during the procedure.After further investigation of the returned sample, it is believed that the crack on the hub could be attributed to the excessive force applied while connecting the hub during the procedure.A review of the retain sample was not performed as the lot number was not provided.A review of the complaints log showed only two occurrences for the last three years from the same account.Therefore, it is recommended that training should be performed with the users/operators in the facility for proper application to prevent future occurrences.The root cause cannot be determined at this time.
Event or Problem Description
Luer hub cracked during use.Nurse used forcepts.Picc was replaced.

• Brand Name: PRIMEPICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks; suite 150; carlsbad CA 92008
• MDR Report Key: 12297534
• Report Number: 2032582-2021-00006
• Device Sequence Number: 3165191
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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: 07/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/09/2021
• 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: Required Intervention