MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 GANG 4-WAY NANOCLAVE STOPCOCK W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number AC205

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Underdose (2542)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received.Investigation is not yet complete.

Event Description

The event involves an ac205, 5 gang 4-way nanoclave® stopcock w/baseplate, rotating luer that the customer reported the multiple luer lock connections broke off after a coronary artery bypass graft.The customer mentioned that one of these ports had epinephrine infusing which negatively impacted the patient after the failure of the luer lock and the patient was stabilized.There was patient involvement with an unspecified adverse event and unspecified patient harm along with a delay in therapy; however, no additional information was provided.

Manufacturer Narrative

H10: one (1) used list # ac205, 5 gang 4-way nanoclave¿ stopcock w/baseplate, rotating luer; lot # 3553144 was received and visually inspected.As received, all five nanoclaves ports were separated from the manifold body due to insufficient uv adhesive coverage at the bonded connection.The probable cause is due to an error in the manual bonding process during assembly.The device history review (dhr) for lot number 3553144 was reviewed and there were no relevant non-conformances found.

• Brand Name: 5 GANG 4-WAY NANOCLAVE STOPCOCK W/BASEPLATE, 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
• MDR Report Key: 10395785
• MDR Text Key: 202552499
• Report Number: 9617594-2020-00309
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: (01)00887709080010(17)221001(10)3553144
• Combination Product (y/n): N
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: AC205
• Device Lot Number: 3553144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EPINEPHRINE, MFR UNK; EPINEPHRINE, MFR UNK
• Patient Outcome(s): Required Intervention