MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE¿ UNIVERSAL VENTED VIAL SPIKE; SYRINGE, PISTON

Catalog Number 011-CH-74

Device Problems Contamination (1120); Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event involved chemoclave¿ universal vented vial spike where it was reported that a small clear fragment of plastic loose at center of ch-74 found during preparation.There is no any unprotected chemo exposure and no contact with the patient or health care provider.

Manufacturer Narrative

Complaint of holes / cuts/ torn can be confirmed based photos shared by customer but no fragment of plastic loose were observed.Since no product sample and mating device were returned for investigation, a comprehensive failure investigation cannot be performed and a probably cause cannot be determined.The device history record for lot 13484378 was reviewed and no non conformities were found that would have led the reported complaint.

• Brand Name: CHEMOCLAVE¿ UNIVERSAL VENTED VIAL SPIKE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17241179
• MDR Text Key: 319093112
• Report Number: 9617594-2023-00309
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00887709124622
• UDI-Public: (01)00887709124622(17)271201(10)13484378
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K080989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-CH-74
• Device Lot Number: 13484378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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
• Treatment: IRINOTECAN 500MG/25ML VIA, MFR UNK.