MAUDE Adverse Event Report: PFM MEDICAL, INC. ASEPT; APPARATUS, SUCTION, PATIENT CARE

Model Number	622289
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was not possible as no lot information was provided.A review of all non-conforming product was conducted.No issues were found pertaining to ref (b)(4).During the investigation of the returned sample, it was found that a small slit was cut into the tubing on the exit site of the drain line.This was likely caused by the user.It is recommended that when applying sutures the operator cuts the excess suture away from the drain line.This limits the chance of cutting into the drain line and creating a leak.The root cause cannot be determined from the information provided.Pfm medical, inc.Will continue to monitor for similar complaints.
Event or Problem Description
Customer and patient reported bubbles present in the drain line throughout the entire drainage procedure.Catheter was placed during the week of (b)(6) 2018.Physician noticed a slit in the catheter close to entry site on (b)(6) 2018.Catheter was removed.Account will wait for patient to heal and potentially place another catheter.Customer was not sure if the slit was caused by anything done by the physician or staff.

• Brand Name: ASEPT
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks way; suite 150; carlsbad CA 92008
• MDR Report Key: 8095184
• Report Number: 2032582-2018-00006
• Device Sequence Number: 13753907
• Product Code: DWM
• UDI-Device Identifier: 04046964317514
• UDI-Public: 04046964317514
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K093307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 622289
• Device Catalogue Number: 622289
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/21/2018
• 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