MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 50ML SYRINGE W/SPINNING SPIROS, RED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CH2050
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation.It has not been received.
Event or Problem Description
The event involved a 50ml syringe w/spinning spiros, red cap that the customer reported a leak of cyclophosphamide during syringe pump administration.They became aware of the issue as spiros can be seen leaking.There was patient involvement and an unspecified adverse event, however, no report of harm.
Additional Manufacturer Narrative
Received two new list #ch2050, 50ml syringe w/spinning spiros¿, red cap; lot #5000347 on september 14, 2021 for evaluation.Two new list #ch2050, 50ml syringe w/spinning spiros¿, red cap (lot #5000347) were received and visually inspected.As received, no visible damage or anomalies were identified.Each sample was leak tested and leakage occurred from the o-ring/poppet interface of the spiros on both samples.The disassembled poppets, o-rings, and posts of the spiros were measured according to design specifications.The o-rings of the two samples failed the outer diameter specification.The reported complaint of leakage can be confirmed on the two samples returned.The probable cause is due to an error during the spiros o-ring molding process.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information: d10 concomitant - 60" (152cm) 0.49 ml, smallbore ext set w/chemoclave¿ spiros¿/red cap, clamp, icu medical, inc.Ln ch3147.

• Brand Name: 50ML SYRINGE W/SPINNING SPIROS, RED CAP
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 12439946
• Report Number: 9617594-2021-00246
• Device Sequence Number: 3779457
• Product Code: ONB
• UDI-Device Identifier: 00887709122314
• UDI-Public: (01)00887709122314(17)250901(10)5000347
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/11/2021

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: 09/01/2025
• Device Model Number: CH2050
• Device Catalogue Number: CH2050
• Device Lot Number: 5000347
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 11/03/2021
• 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: CYCLOPHOSPAMIDE, UNK MFR