MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S.A. DE C.V. VENTED BAG SPIKE, CLAVE®; ADMINISTRATION SETS AND ACCESSORIES

Catalog Number 886-CH-14

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

No product samples were returned for investigation, however, a diagram was provided that described the leak coming from the clave portion of the vented bag set assembly.The device history record for lot 3600944 was reviewed and there were no non-conformances found that would have contributed to the reported complaint.Without the actual complaint sample it is not possible to determine a root cause for the reported leakage.

Event Description

The event involved a vented bag spike, clave that leaked at the clave connection during set-up of chemotherapy before infusion to the patient.The device was replaced with no further problems encountered.There was no patient involvement, no serious injury, no medical intervention required, no blood loss nor chemo exposure.

• Brand Name: VENTED BAG SPIKE, CLAVE®
• Type of Device: ADMINISTRATION SETS AND ACCESSORIES
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S.A. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: patricia sharpe-gregg, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8139096
• MDR Text Key: 129906242
• Report Number: 9617594-2018-00216
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619084592
• UDI-Public: (01)00840619084592(17)230101(10)3600944
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K082836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 886-CH-14
• Device Lot Number: 3600944
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1