MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number B2155

Device Problem No Flow (2991)

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

The event involved a 60" smallbore ext set w/0.2 micron filter, clamp, luer lock where it was reported that the tubing was taken out from supply area to prime medication for patient, and the tubing was difficult to flush with saline.When placed on bd intravenous (iv) pump it was beeping occlusion.It was also reported that several sets of tubing were tried before finding one that would work.The medication was given to patient without problem.There was patient involved and no patient harm reported.

Manufacturer Narrative

The device has been received for evaluation.Investigation is pending.

Manufacturer Narrative

Received: two used.List #b2155, 60" smallbore ext set w/0.2 micron filter, clamp, luer lock; lot #unknown.One new.List #b2155, 60" smallbore ext set w/0.2 micron filter, clamp, luer lock; lot #13677555.Photos were returned showing b2155 package label and a b2155 product assembly connected to a luer lock syringe with fluid in the syringe.The b2155 assembly still had the belly band on the tubing.There was no visible anomaly observed from the photos returned.The returned b2155 smallbore ext sets were all successfully primed without difficulty and leak tested.No leaks were observed at any location along the fluid path.The complaint was unable to be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 60" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, LUER LOCK
• 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: 18065908
• MDR Text Key: 327292186
• Report Number: 9617594-2023-00935
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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: B2155
• Device Lot Number: 13677555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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: INFUSION PUMP, BD.; SALINE FLUSH, UNK MFR.