MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER,; STOPCOCK, I.V. SET

Model Number	B9126
Medical Device Problem Codes	Backflow (1064); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a 100" (254 cm) appx 12.8 ml, 15 drop primary set w/3 microclave®, rotating luer, filter cap, where it was reported the tubing with blue anti-reflux valve is not compliant since the liquid goes back into the tubing.This creates a change in the dosage of the medication to be received.When using propofol, the solution was backing up in the tube.The error could be caught because propofol is well differentiated with its milky hue.They were made aware of the problem during the patient induction period while injecting the drug through the clave of the tubing.There was no blood loss.The tubing was replaced and therapy started.Tubing had to be removed from operational circulation.There was patient involvement, however no report of patient harm.
Additional Manufacturer Narrative
Received: forty-two (42) new.List #(b)(4), primary set, 3 clave y-sites, 100 inch, non-dehp; lot #13539751.It is understood that the molding process, automation, and subsequent packing b9126 primary set is random so the samples that were sent back are randomly selected as if the whole lot population was available to draw from.Using binomial stages sampling plan (95% confidence, 0.10 ucl, n=0, crc handbook of probability and statistics: second edition) this would allow for thirty-five (35) samples to represent the lot population.No damages or anomalies noted.The sets were tested for cracking pressure and back flow per product specifications.The back check valve functioned according to product specifications with no backflow observed.The reported complaint was unable to be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9.Devices returned to mfr on 7/25/2023.

• Brand Name: 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER,
• 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: 17299227
• Report Number: 9617594-2023-00343
• Device Sequence Number: 19779270
• Product Code: FMG
• UDI-Device Identifier: 00887709013025
• UDI-Public: (01)00887709013025(17)260201(10)13539751
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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: 02/01/2026
• Device Model Number: B9126
• Device Catalogue Number: B9126
• Device Lot Number: 13539751
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: PROPOFOL, UNK MFR; SYRINGE, UNK MFR
• Patient Sex: Unknown