MAUDE Adverse Event Report: PFM MEDICAL, INC. PRIMEPICC

Model Number	PFM2CT5D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No investigation could be performed on the picc product since it was not returned to pfm medical, inc.There is not enough information to confirm or deny that the picc product was used as per the ifu.Given the similarity to another complaint, (b)(4), it is possible that the failure was induced by excessive force being applied to the hub when the nurse and/or physician was connecting or disconnecting the needle free valve, syringe or other device.Without access to the picc product, however, pfm medical was unable to confirm the root cause for the cracked and leaking hub.A review of the device history records showed no deviations or discrepancies associated with lot 1604-033.A nonconformance report review determined that there are no open or closed ncr's for the lot in question.Complaint records were reviewed, and a similar complaint dating back to (b)(6) 2012 was identified in (b)(4).The failure mode in question is already captured in the picc design fmea, fmea (b)(4).(b)(4).No corrective or preventative action is recommended at this time, and pfm medical will continue to monitor for incidents with similar failure modes.
Event or Problem Description
Picc cracked and leaking.Replaced on (b)(6) 2016.

• Brand Name: PRIMEPICC
• Common Device Name: PICC
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks way; suite 150; carlsbad CA 92008
• MDR Report Key: 8313061
• Report Number: 2032582-2016-00012
• Device Sequence Number: 11312198
• Product Code: LJS
• UDI-Device Identifier: 00813623013728
• UDI-Public: 00813623013728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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: 09/01/2018
• Device Model Number: PFM2CT5D
• Device Catalogue Number: PFM2CT5D
• Device Lot Number: 1604-033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2016
• Initial Report FDA Received Date: 02/06/2019
• 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: 73 YR