MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EFFLUENT SAMPLE BAG; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C4476
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an effluent sample bag was leaking.While the patient was draining into the effluent sample bag at the clinic, it was reported that the site next to the port was leaking.The nurse stated that the bag did not look like it had been sealed in all the way.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Correction d10, h3, h10.D10: device avail.For eval?: (remove yes and change to no, as no sample was returned for evaluation.) d10: date returned to mfr: (remove 10/12/2020, the device was not returned).H3: device returned for evaluation: (remove yes and change to no).H3: select reason for no evaluation: (remove other).H10: remove statement: (the device was received and is currently awaiting evaluation.).Additional information: h6.H10: 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: EFFLUENT SAMPLE BAG
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10729500
• Report Number: 1416980-2020-06597
• Device Sequence Number: 3456852
• Product Code: FKX
• UDI-Device Identifier: 00085412007717
• UDI-Public: (01)00085412007717
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K923065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: Lay User/Patient
• Device Expiration Date: 10/15/2024
• Device Catalogue Number: 5C4476
• Device Lot Number: H19J15056
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRANSFER SET