MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE¿ MANIFOLD W/CHECK VAL; STOPCOCK, I.V. SET

Catalog Number 011-AM6136

Device Problem Fluid/Blood Leak (1250)

Patient Problem Sepsis (2067)

Event Date 08/05/2022

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 25-week-old baby was found to have sepsis following a leak that occurred during an infusion involving a 25 cm (10") pur yellow smallbore ext set, 6-port nanoclave¿ manifold w/check valve, nanoclave¿, 4-way nanoclave¿ stopcock (red ring), rotating luer in the pediatric intensive care unit.The leak was reported to have occurred at the level of the small yellow extension while infusing the following medications: parenteral nutrition by numetah g13, insulin, morphine, primene.The clinician noticed that the sheet was wet and that the liquid was coming out at the end of the 6-port manifold.The leak was reported to be in contact with the patient.The sheet was reported to have been wet and subsequently changed.In addition, the central catheter line was replaced according to hospital service protocols.The reporting clinician is unable to attribute the patient¿s sepsis to this incident.There was a delay in therapy; however, no additional medical intervention was reported.No additional information is available at this time.

Manufacturer Narrative

Received one (1) used 011-am6136 pur yellow smallbore ext set and one (1) new 011-am6136 pur yellow smallbore ext set for inspection.As received, the collar on the male luer was freely spinning on the used set.The sets were tested according to product specifications.On the used set, there was a channel leak at the connection of the male luer to the female luer of the yellow tubing.The male collar was cut and the bonded connection of the male luer and female luer of the yellow tubing was disassembled.There was no leakage on the new set.The new set met all design specifications.The reported complaint can be confirmed on the received one (1) used 011-am6136 pur yellow smallbore ext set.The probable cause of the channel leak is due to an incomplete bond during manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information: product receipt date 10/13/2022.

• Brand Name: 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE¿ MANIFOLD W/CHECK VAL
• 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: 15380056
• MDR Text Key: 306269332
• Report Number: 9617594-2022-00261
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709092334
• UDI-Public: (01)00887709092334(17)270201(10)5782914
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-AM6136
• Device Lot Number: 5782914
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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
• Treatment: CENTRAL CATHETER LINE, UKN MFR; INSULIN, UKN MFR; MORPHINE, UKN MFR; PARENTERAL NUTRITION BY NUMETAH G13; PRIMENE
• Patient Age: 25 WK