MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 123" (312 CM) APPX 16.0 ML, 10 DROP PRIMARY SET W/3 MICROCLAVE®, 4-WAY STOPCOCK,; STOPCOCK, I.V. SET

Catalog Number	B9900-200
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone has a cell # (b)(4).The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event involved a 123" (312 cm) appx 16.0 ml, 10 drop primary set w/3 microclave®, 4-way stopcock, rotating luer where it was reported that a pre-op nurse spiked an iv bag and when she squeezed the chamber to prime the tubing, she noticed what looks like a hair (particulate) inside the tubing chamber.There was unknown patient involvement and unknown patient harm reported.
Additional Manufacturer Narrative
Received one used sample, list #b9900-200 was returned for evaluation.As received it was confirmed the presence of strand of hair inside the drip chamber.No additional damage or anomalies were confirmed.Complaint of particulate matter can be confirmed.The probable cause was due to gowning error controls at manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 123" (312 CM) APPX 16.0 ML, 10 DROP PRIMARY SET W/3 MICROCLAVE®, 4-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: 18048891
• Report Number: 9617594-2023-00909
• Device Sequence Number: 12773032
• Product Code: FMG
• UDI-Device Identifier: 00887709016552
• UDI-Public: (01)00887709016552(17)280801(10)13725466
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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 Catalogue Number: B9900-200
• Device Lot Number: 13725466
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: IV BAG, MFR UNK
• Patient Sex: Unknown