MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 169 CM (67") PUR YELLOW SMALLBORE EXT SET W/NANOCLAVE 4-WAY STOPCOCK, ROTATING; STOPCOCK, I.V. SET

Catalog Number 011-CH3569

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint of separation can be confirmed on the returned one used 69 cm (67") pur yellow smallbore ext set.As received the 59" tubing was detached from the male luer adaptor.The male luer adaptor was not returned for evaluation.There was no tearing or deformation observed on the tubing.The end of the tubing is angled and this is typical of contact with a sharp object.However, without the returned of the distal male luer the probable cause of the separation cannot be determined.The device history record (dhr) and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

Event Description

The event involved a 169 cm (67") pur yellow smallbore ext set w/nanoclave® 4-way stopcock, rotating luer w/filter cap where the tubing became unstuck from the luer lock cap causing a leak of doxorubicin during infusion on a pediatric patient.The baby had chemotherapy on their garment, on the skin and the bed sheets; however, there were no consequences for the baby or the person involved.The chemotherapy leak was cleaned according to the chemical spill protocol.The facility verified the concerned lots and devices.The device was not replaced with no further problem encountered.There was no delay in therapy, however there was a loss of product and the baby did not receive the entire intended dose.There was no blood loss and no need for medical intervention.Although there was patient involvement, there was no adverse event/human harm.This captures the first of two events reported.

• Brand Name: 169 CM (67") PUR YELLOW SMALLBORE EXT SET W/NANOCLAVE 4-WAY STOPCOCK, ROTATING
• 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: 12269317
• MDR Text Key: 264813027
• Report Number: 9617594-2021-00221
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619088088
• UDI-Public: (01)00840619088088(17)251101(10)5065247
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-CH3569
• Device Lot Number: 5065247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• 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: DOXORUBICINE, MFR UNK; INFUSION BAG, MFR UNK