MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	MC3302
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, a 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave® clear, clamp, rotating luer was found to be occluded during patient use.The incident involved the product being connected to the vygon 1fr peripherally inserted central catheter (picc) line (the smallest catheter that they use) which was removed due to suspicion of impaired forward flow of fluid through the microclave.When the infusion tubing was first disconnected from the bonded microclave, the microclave septum was noted to be stuck in the engaged/depressed position.No other cracks or leaking along the extension set were noted.When the extension sets were replaced with new ones, forward flow was confirmed by clinical staff, and improvement in the patient's status (low blood sugar) was noted.They have only noted this issue with their 1fr picc catheter which is not widely used.
Additional Manufacturer Narrative
A series of photos were shared by the customer, where 2 different items #mc3302 are observed marked as a and b.In sample a, a stick down on the shunltees microclave is observed.Sample b doesn¿t show any damage.Two (2) used list #mc3302, 7" with an unknown solution residual inside each of the sets, the sample a / #2 a silicone plug was observed to be stuck down.The other sample doesn't present any damage.No additional damage was observed, and no mating device was returned for evaluation.The returned set without stick down was activated once with a syringe and no stick down was observed.The sample with stick down was dissembled and an intermittent lubrication on spike was confirmed.Complaint of silicone sleeve stuck down can be confirmed.The probable cause is typically due to an error during the lubrication process at salt lake city.

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, CLAMP, ROTATING
• 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: 19945714
• Report Number: 9617594-2024-01105
• Device Sequence Number: 7126734
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: (01)00887709037267(17)290501(10)14018513
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC3302
• Device Lot Number: 14018513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown