MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE; STOPCOCK, I.V. SET

Catalog Number MC330419

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It has not been received.

Event Description

The event involved a 102" (259 cm) appx 8.2 ml, pur standardbore/smallbore transfer set w/microclave® clear, dual check valve, 1.2 micron filter, luer lock that the customer reported accumulated air when the syringe filled with iv lipid.The customer was made aware during infusion.There was patient involvement, however no report of harm since it did not reach the patient and there was no unexpected or prolonged care.The report captures the second of two events.

Manufacturer Narrative

H10: one used list# mc330419, transfer set (lot# 4605718) and one 10 ml bd syringes were received on october 15, 2020 for evaluation.As received, the 1.2 micron filters the set was wetted out and filled with lipid residuals.The microclave housing was also filled with lipid residuals.The probable cause of the lipid residuals within the microclave housing is unknown.No other visible damage or anomalies were observed.The set was primed and leak tested according to product performance specifications.The 1.2 micron filter was found to be clogged.The probable cause of the occlusion is due to the filter becoming clogged with lipids during use.Leakage was also confirmed from the microclave/smallbore tubing bond the set.The reported complaints can be confirmed on the returned set.The probable cause of the channel leaks is due to insufficient solvent coverage applied during the manual bonding process.A dhr lot# 4605718 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE
• 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
• MDR Report Key: 10642892
• MDR Text Key: 214810628
• Report Number: 9617594-2020-00436
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

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: MC330419
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIPIDS, UNK MFR; UNSPECIFIED SYRINGE, MFR UNK