MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 16 CM (6") PUR EXT SET W/MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-MC33093

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 02/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return to the manufacturer for investigation; it has not been received.

Event Description

The event involved a 16 cm (6") pur ext set w/microclave® clear, clamp, rotating luer.The customer stated that the bidirectional valve detaches from the extension it is attached to.The administration of the drug stops when the valve detaches.There was blood loss from the catheter, through the extension, and it spread in the bed of the patient.

Manufacturer Narrative

H10: additional information can be found in b5.

Event Description

Additional information was received from the customer stating that the drug administered at the time of the event was "mainly nacl hydration solution".The customer stated that the device was rubbing against the linens of the bed and that caused the disconnection of the valve.

Manufacturer Narrative

H10: no product samples, videos, or photographs were returned for investigation.The dhr for lot number 4159221 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.Additional information found in b5 and d10.

Event Description

Additional information was received from the customer indicating that there was no need for medical intervention and no drug was administered at the time of the event.The customer further clarified that blood flowed from the catheter into the extension without the valve which had detached.The valve detached at the moment of priming.The patient¿s bed was properly cleaned and the linen was changed.

Manufacturer Narrative

D10 - date returned to mfg: 7/17/2020.H10: one (1) used list# 011-mc33093 was received and visually inspected.As received, the shunt was separated from the male luer of the microclave.Little to no solvent was present within the shunt and on the male luer post of the microclave.No additional damage or anomalies were seen.The tubing and shunt were measured and found to be within product specification.No evidence of stretching or elongation of the tubing was seen.The reported complaint of a disconnection was confirmed.The probable cause is insufficient solvent due to an error during the manual bonding process during manufacturing.

• Brand Name: 16 CM (6") PUR EXT SET W/MICROCLAVE CLEAR, CLAMP, 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: 9751201
• MDR Text Key: 206574114
• Report Number: 9617594-2020-00053
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619057169
• UDI-Public: (01)00840619057169(17)240701(10)4159221
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33093
• Device Lot Number: 4159221
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NACL, UNK MFR