MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 26 CM (10") EXT SET W/MICROCLAVE® CLEAR, BCV-CLAVE® (RED RING), CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number 011-MC33112

Device Problem No Flow (2991)

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

Event Date 10/01/2023

Event Type  malfunction  

Event Description

It was reported that, on an unknown date, an ext set w/2 clave¿ clear generated a no-flow event.First, the fludeoxyglucose (fdg) injection via the micro-valve and non-return valve route without difficulty.Then, it is impossible to administer the iodinated contrast product on this same route.The y remains functional in recent weeks.The problem has been encountered several times.There were no undesirable clinical consequences, and nobody has been hurt.There was no delay in therapy, and it was completed.There was no blood loss considered clinically significant.The drug administered was 18 fdg.There was no medical intervention was provided to the healthcare professional.There was no leak to come into contact with the patient.The leak was cleaned up according to facility protocol with no specific kit.The patient received the full intended dose.There was no patient harm reported.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

The returned 011-mc33112 ext set was successfully primed through the proximal microclave and the midline y-clave without evidence of occlusion.The complaint was unable to be replicated or confirmed.The dhr for lot 13605538 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: 26 CM (10") EXT SET W/MICROCLAVE® CLEAR, BCV-CLAVE® (RED RING), CLAMP, 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17953860
• MDR Text Key: 325921815
• Report Number: 9617594-2023-00840
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058357
• UDI-Public: (01)00840619058357(17)280401(10)13605538
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33112
• Device Lot Number: 13605538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• 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: 18 FDG, UNK MFR