MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP; STOPCOCK, I.V. SET

Catalog Number 011-H3393

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation.However; it has not yet been received.Without the return of the sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined at this time.

Event Description

It was reported that a nurse from the outpatient department, upon opening the sterile packaging, noticed the presence of an impurity in the connection site of the infusion set.The device has been quarantined and has not been used.There is no patient involvement and no adverse events/human harm.No additional information is available at this time.

Manufacturer Narrative

The complaint of a particulate inside the fluid path can be confirmed on the returned one (1) open/unused.List #011-h3393, 28 cm (11") add-on set w/2 check valves, vented cap, non-dehp; lot #5872617.As received there was a white translucent particulate inside the tubing.The particulate was 5 in^2 in size.The large size of the particulate far exceeds the product specification.The particulate was submitted to an ft-ir to determine the origin of the particulate.The particulate was determined to have a strong correlation with pvc which is the same material as the tubing.The probable cause of the particulate inside the tubing is tubing debris from the manufacturing site.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information: d9 - date returned to mfg: 8/8/2022.

• Brand Name: 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP
• 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.
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest 60045 ; 2247062300
• MDR Report Key: 15163526
• MDR Text Key: 302569035
• Report Number: 9617594-2022-00224
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619058043
• UDI-Public: (01)00840619058043(17)270301(10)5872617
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3393
• Device Lot Number: 5872617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• 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