MAUDE Adverse Event Report: ICU MEDICAL INC. RED CAP; SYRINGE, PISTON

Catalog Number BOPCH200SCH

Device Problems Break (1069); Crack (1135); Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

Event Type  Injury  

Event Description

Hospital pharmacy has started using chemo clave closed system transfer device products (spinning spiros) for pharmacy and rn safety w/ chemotherapy preparation and admin.We have had several problems w/ various parts of these systems from icu medical inc: leaking, breaking, falling off the syringe, etc.We have reported each to the mfr via the icu medical rep.I reported a malfunction with the spinning spiros which occurred to mfr.Fludarabine iv syringe and tacrolimus ivpb prepared for multiple different pt and delivered to unit.Rn had just begun setup, but did not begin any infusion, and came to pharmacist w/ broken spinning spiros (cracked at seam) or fallen off the syringe or fallen off the tubing even after tech and pharmacists have double checked they were secured prior to delivery.These closed systems are supposed to aid w/ safety and decrease risk of exposure to hazardous medications.However, when the leak, crack and break or fall off when about to infuse, they are putting associates and event pt at risk.Fda safety report id# (b)(4).

• Brand Name: RED CAP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ICU MEDICAL INC.
• MDR Report Key: 9818280
• MDR Text Key: 183345532
• Report Number: MW5093665
• Device Sequence Number: 2
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/06/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: BOPCH200SCH
• Device Lot Number: 4549835
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 12 YR
• Patient Weight: 14