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	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	08/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.Testing and investigation is not complete.
Event or Problem Description
The customer reported a 5 gang 4-way nanoclave stopcock w/baseplate had a manifold failure that occurred in a patient room and resulted in a spill of ifosfamide.The spill was on the floor between the bathroom and bed.There was a delay in therapy as the amount of chemo remaining had to be calculated, orders written, double signed, released and chemotherapy remade.There was no direct harm.
Additional Manufacturer Narrative
H10: one (1) used partial set, list # ac205, 5 gang 4-way nanoclave¿ stopcock w/baseplate, rotating luer; lot # 3602315, two (2) used swabcaps green; manufacturer - unknow were received for evaluation.The distal nanoclave port was separated from the stopcock body on the returned device.Visual examination of the bond interface revealed sparse adhesive.Subsequent assembly integrity testing of the remaining intact ports each met functional expectations.When the bonds were forcefully broken, the port bond adhesive was amply applied.The complaint was confirmed.The probable cause is an inadequate uv bond during assembly in ensenada.The device history review for lot number 3602315 was reviewed and there were no relevant non-conformances found.Additional information in h3.

• 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; colonia rancho santa clara, ma; ensenada, b.cfa. IL 22790 ; MX 22790
• MDR Report Key: 8966846
• Report Number: 9617594-2019-00299
• Device Sequence Number: 11273088
• Product Code: FMG
• UDI-Device Identifier: 00887709080010
• UDI-Public: (01)00887709080010(17)230101(10)3602315
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: AC205
• Device Lot Number: 3602315
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1