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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Underdose (2542)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.Investigation is not yet complete.
Event or Problem 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.
Additional 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
• 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: 10395785
• Report Number: 9617594-2020-00309
• Device Sequence Number: 11403584
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: (01)00887709080010(17)221001(10)3553144
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• 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): 07/20/2020

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: 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
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/16/2020
• 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: EPINEPHRINE, MFR UNK; EPINEPHRINE, MFR UNK
• Outcome Attributed to Adverse Event: Required Intervention