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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unknown date involving a 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave® clear, clamp, rotating luer.The report stated that had an incident with a stuck down clave, this time with a larger bore picc catheter.It caused a complete block of forward flow of fluid, verified by the bedside nurse attempting to flush manually through the microclave.The reported added that the picc line has occluded so the patient will need a new picc line if they cannot clear the occlusion.The medication being infused were tpn/lipids, caffeine, and antibiotics.Prevantics was being used and the set been in use for 36 hours.There was patient involvement and unknown harm.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
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, stick down on the shunltees microclave is observed.Sample b doesn¿t show any damage.One (1) used.List #mc3302, 7" was returned for evaluation.As received the silicone plug was observed to be stuck down, no mating device was returned for evaluation.The shuntless microclave was dissembled and insufficient solvent on the spike was confirmed, no additional damage or anomalies were observed.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.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 20310125
• Report Number: 9617594-2024-01344
• Device Sequence Number: 15670090
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: (01)00887709037267(17)290601(10)14061258
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: MC3302
• Device Lot Number: 14061258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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: ANTIBIOTIC, MFR UNK; CAFFEINE, MFR UNK; LIPIDS, MFR UNK; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK
• Patient Sex: Unknown