MAUDE Adverse Event Report: PFM MEDICAL, INC. ASEPT; PERITONEAL DRAINAGE CATHETER KIT

Model Number	622284
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was conducted and no deviations, issues or nonconformances were found.The risk management file was reviewed.No similar complaints for this lot or different lots have been received.Image was provided by the reporter and clearly shows that the barbed portion of the drain only valve (used outside the body) is broken off.The device was returned and evaluated and confirmed that the bard portion was broken off and a crack is observed in the valve body above the connection.Only the drain only valve was returned and not the catheter.Unclear if the catheter was placed in the patient.The root cause is unable to be determined.The likely root cause is application of excessive force to the joint between the catheter and the drain only valve causing the crack and barb portion to break off.
Event or Problem Description
Physician was twisting the catheter together during a procedure and noted that it was leaking and was cracked.Another asept catheter was used to complete the procedure.

• Brand Name: ASEPT
• Common Device Name: PERITONEAL DRAINAGE CATHETER KIT
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks way; suite 150; carlsbad, ca
• MDR Report Key: 10311212
• Report Number: 2032582-2020-00004
• Device Sequence Number: 19561336
• Product Code: PNG
• UDI-Device Identifier: 04046964317330
• UDI-Public: 04046964317330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 08/31/2020
• Device Model Number: 622284
• Device Catalogue Number: 622284
• Device Lot Number: 1912-006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/22/2020
• 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