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

Catalog Number	5C4480C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 six (6) patient line extension sets were leaking.The leaks were observed from the patient line connector end of the set during peritoneal dialysis (pd) therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The patient stated they continued to use the extension sets after they tightened it (previously not reported).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Correction: b4/f8: date of this report in mdr follow up #2 is being corrected from blank to 03/25/2021.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11273219
• Report Number: 1416980-2021-00361
• Device Sequence Number: 4997765
• Product Code: KDJ
• UDI-Device Identifier: 00085412087382
• UDI-Public: (01)00085412087382
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K925403
• 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,Followup,Followup
• Report Date (Section B): 07/29/2021

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: 07/02/2022
• Device Catalogue Number: 5C4480C
• Device Lot Number: H20G02064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 03/08/2021; 07/01/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/02/2021; 03/25/2021; 07/29/2021
• 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: NI.