MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ZUSPRITZPORT; STOPCOCK, I.V. SET

Catalog Number SN1009

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.

Event Description

The event occurred on a unknown date in (b)(6) 2020.The event involved a (b)(4) that the customer reported during an unknown infusion to a child the silicone membrane simply flew out and the drugs leaked in the bed unnoticed and uncontrolled.The customer reported the infusion was to maintain blood sugar levels.The doctor mentioned the child¿s blood sugar level was only 11.A bolus of an unknown medication was given immediately to get the blood sugar back to normal.No more information was provided at this time.

Manufacturer Narrative

H10: one used and two new list# sn1009 sets were returned on (b)(6)2020 for investigation and visually inspected.As received, the one (1) used set was found with the injection port septum separated from the port.A needle puncture was identified on the silicone septum.(b)(4) of the(b)(4) returned sn1009 sets (one (1) new and one (1) used), were confirmed to have an inadequate injection port stakes which resulted (or could result) in the septum becoming dislodged when the injection port is access with a needle.The probable cause is an inadequate injection port stake during manual assembly.A device history review (dhr) lot# 4332813 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: ZUSPRITZPORT
• 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
• MDR Report Key: 9896795
• MDR Text Key: 219548571
• Report Number: 9617594-2020-00092
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619039752
• UDI-Public: (01)00840619039752(17)220801(10)4332813
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: SN1009
• Device Lot Number: 4332813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1