MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE CLEAR, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number	MC33098
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for investigation.It has not been received.
Event or Problem Description
The event involved a 4" (10 cm) appx 0.40 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, rotating luer that the customer reported a partial disconnection and leaking resulting in hypoglycemia of a baby in the nicu.The medications infusing were tpn, lipids, and d20w.The d20w was infusing for only 4 hours and was unknowingly leaking.The customer stated the device was in use between 18 to 36 hours.The patient¿s status upon admission was hypoglycemia.During the event the patient was borderline stable then hypoglycemic.The patient returned to a normoglycemic status after the tubing was changed.The medical intervention was the administration of d20w and the decrease of tpn.The entire set up was changed, not the umbilical venous catheter, the patient¿s sugar normalized within an hour, and few hours later the d20w was discontinued.The event did not prolong the hospital stay.
Additional Manufacturer Narrative
H10: received three new sister samples list# mc33098, 4" (10 cm) appx 0.40 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, rotating luer.Lot# 4799556 on (b)(6) 2020 for evaluation.Three (3) new list# mc33098, trifuse ext sets (lot# 4799556) were received and visually inspected.As received, no damage or anomalies were seen.No used devices or mating devices were returned.All three (3) samples were functionally tested.The retention of the male spin luers met the specification performance requirements with no disconnection or leakage identified.The reported complaint could not be replicated or confirmed.A device history review (dhr) lot# 4799556 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE CLEAR, 3 CLAM
• 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
• MDR Report Key: 10572532
• Report Number: 9617594-2020-00410
• Device Sequence Number: 1270308
• Product Code: FMG
• UDI-Device Identifier: 00887709037366
• UDI-Public: (01)00887709037366(17)250401(10)4799556
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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 Expiration Date: 04/01/2025
• Device Catalogue Number: MC33098
• Device Lot Number: 4799556
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BI-FUSE, ICU MEDICAL INC. UNK LIST AND LOT; DEXTROSE 20% IN WATER (D20W), MFR UNK; LIPIDS, UNK MFR; TOTAL PARENTAL NUTRITION, MFR UNK; BI-FUSE, ICU MEDICAL INC. UNK LIST AND LOT; DEXTROSE 20% IN WATER (D20W), MFR UNK; LIPIDS, UNK MFR; TOTAL PARENTAL NUTRITION, MFR UNK
• Outcome Attributed to Adverse Event: Required Intervention