MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") SET PER INFUSIONE PER POMPA CON DUE CLAVE CONNECTOR E PERFORATORE C; STOPCOCK, I.V. SET

Catalog Number 011-H1267

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.The dhr was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The dhr for lot 5134854 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

Event Description

The event occurred on an unspecified date and involved a 28 cm (11") set per infusione per pompa con due clave® connector e perforatore con filtro that the customer reported that leaked dacarbazine onto the liberal nurse's hand.Upon changing the chemotherapy bag, the nurse touched the tubing to check it and it was then discovered that the fluid was leaking onto his hand.A slit was noted on the tubing.The decontamination protocol following contact with a cytotoxic was followed.The patient received the full dose of chemotherapy and there was very little wastage.There was patient involvement, however, there was no report of adverse event, no need for medical intervention (for the patient or the liberal nurse) and there was no blood loss.

• Brand Name: 28 CM (11") SET PER INFUSIONE PER POMPA CON DUE CLAVE CONNECTOR E PERFORATORE C
• Type of Device: STOPCOCK, I.V. SET
• 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: 12232291
• MDR Text Key: 264072367
• Report Number: 9617594-2021-00210
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619008284
• UDI-Public: (01)00840619008284(17)260101(10)5134854
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1267
• Device Lot Number: 5134854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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