MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 80" (203 CM) Y-TYPE 150 ML BURETTE SET (MICROCLAVE®, SHUT-OFF) W/3-WAY STOPCOCK,; STOPCOCK, I.V. SET

Catalog Number	B9733
Medical Device Problem Codes	Contamination (1120); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of disconnection / loose connection on item b9733 could not be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history report (dhr) for lot#5643723 was reviewed and no non conformities were found that would have led the reported complaint.Additional contact information: (b)(4).
Event or Problem Description
The event involved a 80" (203 cm) y-type 150 ml burette set (microclave®, shut-off) w/3-way stopcock, clave®, graduated adapter, rotating luer, 1 ext where a wet contamination during peritoneal dialysis (pd) was reported.A disconnection of pd setup from drainage bag at the orange flexible connector.There was patient involvement but no harm.

• Brand Name: 80" (203 CM) Y-TYPE 150 ML BURETTE SET (MICROCLAVE®, SHUT-OFF) W/3-WAY STOPCOCK,
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17845235
• Report Number: 9617594-2023-00778
• Device Sequence Number: 20677960
• Product Code: FMG
• UDI-Device Identifier: 00887709015043
• UDI-Public: (01)00887709015043(17)261001(10)5643723
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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: Health Professional
• Device Expiration Date: 10/01/2026
• Device Catalogue Number: B9733
• Device Lot Number: 5643723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED DRAINAGE BAG, MFR UNK; UNSPECIFIED PERITONEAL DIALYSIS SET UP, MFR UNK
• Patient Sex: Unknown