MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 42" EXT SET W/2 CLAVE, 2 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number AH7223

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a 42" ext set w/2 clave¿, 2 clamps, rotating luer that the customer reported air in the line.The customer stated the set up was a primary iv line with an infusion pump, attached to the extension set, which was connected to a swivel iv set, and then connected to the patient.The set was attached to the ceiling of the cage to prevent tangling of the line.The customer went to examine the patient and noticed the absorbent pad was wet.The set was leaking from one of the two clave connectors in the extension set.The customer stated it appeared the inner piece of the clave was stuck keeping the system open and allowing fluid to leak out.The customer stated it also seemed to allow air into the line.The air was traveling through the rest of the extension set into the swivel set.The physician immediately shut off the infusion pump.It was reported the device was in use for 40 plus minutes.The device was replaced and no further problems encountered.There was patient involvement, however, no report of injury, no blood loss, no adverse event, no delay in critical therapy, and no medical or surgical intervention required.

Manufacturer Narrative

No product samples were returned for investigation, however, photographs were received and evaluated.The photos show one ah7223 extension set in a plastic bag.In the first photo, a microclave seal that is stuck down can be seen.No mating devices are shown or reported in the complaint description.The reported complaint of a seal stick down that lead to leakage can be confirmed based on the photos provided.However, without a returned sample a probable cause cannot be determined.The device history review (dhr) for lot number 4558594 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

Manufacturer Narrative

H10: one used list # ah7223, extension set (lot # 4558594) was received on (b)(6)2020 and evaluated.As received, one (1) of the two (2) y-claves exhibited a seal stick down.The seal was observed to be torn.No other damage or anomalies were identified.No mating devices were returned.The set was primed and leak tested according to product performance specifications.Leakage occurred through the damaged y-clave seal.Subsequent disassembly of the clave revealed no spike damage or anomalies.The reported complaint of leakage can be confirmed.The leakage occurred through the damaged seal of the y-clave.The probable cause of the seal tearing is due to access with an incompatible mating device during use.Additional information in sections d10, h2, h3, h6.

• Brand Name: 42" EXT SET W/2 CLAVE, 2 CLAMPS, ROTATING LUER
• 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: 9953679
• MDR Text Key: 208986150
• Report Number: 9617594-2020-00112
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709075382
• UDI-Public: (01)00887709075382(17)250101(10)4558594
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AH7223
• Device Lot Number: 4558594
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFUSION PUMP, UNK MFR; PRIMARY IV SET, UNK MFR; SWIVEL IV SET, UNK MFR