MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAVE®, CLAMP, CHECK VALVE W/LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B90051
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A picture was returned showing the samples inside a biohazard bag.Received one (1) infusion device attached to an extension tubing with filter, one (1) used list #b90051 smallbore ext set attached to an infusion device, two (2) used list #b90051 smallbore ext sets, and two (2) infusion devices attached to extension tubing and one (1) used list #b90051 smallbore ext set.As received no damage or anomalies were noted on sample 1.Samples 2-5 were received with the tubing disconnected from the back check valve adaptor on the smallbore ext sets.No adaptor assembly was received for evaluation for samples 5.No additional damage or anomalies were observed.Inspection of the bonding sites showed insufficient to no solvent on samples 2-5.All tubing and bond pockets were found to meet specifications.The complaint of breakage can be confirmed due to the separation found.The probable cause is due to insufficient solvent application during assembly.The lot history was reviewed, no relevant nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event occurred on an unspecified date and involved a 9" smallbore ext set w/0.2 micron filter, clave®, clamp, check valve w/luer lock where it was reported there was breaking occurring at the male luer end side right as the tubing ended and became thicker.It was also mentioned that it was a clean break.The event occurred during infusion of lipids.There was patient involvement and unknown human harm.This report captures 3 occurrences.

• Brand Name: 9" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAVE®, CLAMP, CHECK VALVE W/LUER LOCK
• 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: 19990714
• Report Number: 9617594-2024-01140
• Device Sequence Number: 12897573
• Product Code: FMG
• UDI-Device Identifier: 00887709011991
• UDI-Public: (01)00887709011991(17)290201(10)13909307
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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: B90051
• Device Lot Number: 13909307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: LIPIDS, UNK MFR
• Patient Sex: Unknown