MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.4 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number B2003

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Hypoglycemia (1912); Low Blood Pressure/ Hypotension (1914)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

One used list# b2003, 60" (152 cm) appx 0.4 ml, smallbore ext set w/clamp, rotating luer (lot# unknown) was received.As received, the tubing was partially severed.The damage had some elements of a clean cut from a sharp instrument and a ragged edge.A clamp impression on the tubing was also seen towards the female luer end of the set.The clamp was inspected and no sharp edges were identified.No other damage or anomalies were identified on the set.The reported complaint of damaged tubing can be confirmed.It is unknown how, when, or where the tubing became cut.A device history review could not be conducted because no lot number(s) was/were identified.

Event Description

The event involved a 60" (152 cm) appx 0.4 ml, smallbore ext set w/clamp, rotating luer that during an infusion of 20% dextrose and epinephrine, a crack was noted, with the 20% dextrose back flowing into the cracked epinephrine tubing.This resulted in the patient having a low glucose and low blood pressure.Once the crack was identified, the tubing was changed, correcting the low blood pressure.The patient was treated with glucose.There was no delay in therapy reported.

• Brand Name: 60" (152 CM) APPX 0.4 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER
• Type of Device: 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10455147
• MDR Text Key: 205118774
• Report Number: 9617594-2020-00347
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B2003
• Device Catalogue Number: B2003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1