MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME EXTENSION SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C4464P
Medical Device Problem Code	Cut In Material (2454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there were several slices found in the tubing of a 12-inch drain extension set before use.The patient was not able to specify how many defective units were involved.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• MDR Report Key: 7594295
• Report Number: 1416980-2018-03585
• Device Sequence Number: 1776171
• Product Code: FKX
• UDI-Device Identifier: 00085412030555
• UDI-Public: (01)00085412030555
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K833065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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: Lay User/Patient
• Device Expiration Date: 01/17/2023
• Device Catalogue Number: 5C4464P
• Device Lot Number: H18A17101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR