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

Catalog Number 5C4476

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was an "eyelash" in an effluent sample bag.This was found during unspecified process step of peritoneal dialysis therapy; however, there was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : one actual sample was received for evaluation.A visual inspection was performed and it was noted that particulate matter (eyelash) was on the effluent sample bag.During sample evaluation, it was noted that the particulate matter was outside of the effluent sample bag.The reported condition was verified.The direct cause of the event was determined to be manufacturing related.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EFFLUENT SAMPLE BAG
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8741881
• MDR Text Key: 149487980
• Report Number: 1416980-2019-03499
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412007717
• UDI-Public: (01)00085412007717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2023
• Device Catalogue Number: 5C4476
• Device Lot Number: H18H09020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1