MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLEXICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4456
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a minicap had no iodine; further described as ¿the dye had not released and noticed the dye had dried out¿.This was observed during use of the device of peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The event occurred on an unspecified date of june 2022.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction made to h6: investigation conclusions: replace d15 with d1102.Additional information added to h10: the patient used expired product.This was noticed after use due to dry iodine.The flexicap product should not be used if the iodine is dry per requirements of the patient information leaflet.The expiry date of the product should also be checked prior to use.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction made to b5: it was reported that a flexicap (previously submitted as minicap) had no iodine; further described as ¿the dye had not released and noticed the dye had dried out¿.Additional information was added to h4, h6 and h10.H4: the lot was manufactured in may 2021.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: FLEXICAP
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SWINFORD; foxford road; swinford ; EI
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15103537
• Report Number: 1416980-2022-03839
• Device Sequence Number: 4588070
• Product Code: KDJ
• UDI-Device Identifier: 00085412349145
• UDI-Public: (01)00085412349145
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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: 04/28/2022
• Device Catalogue Number: 5C4456
• Device Lot Number: 21E04H25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 07/29/2022; 09/09/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/15/2022; 09/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male