MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/CLAVE¿, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number MS933

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

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

Event Date 06/22/2023

Event Type  malfunction  

Manufacturer Narrative

The actual sample was not returned for evaluation, however, two photo samples were provided.One photo shows a patient's arm connected to an icu medical device and there is blood observed around the arm and the blanket, however it's not clear where the blood came from.In the second photo the same item is observed, but now disconnected.It is not clear how the product was connected.No additional damage or abnormally were observed.Complaint of product did not connect properly to line cannot be confirmed, due to no product sample being returned for evaluation and a probable cause cannot be determined.The device history review (dhr) for lot 13641832 was reviewed and no non conformities were found that would have led to the reported complaint.(b)(6).

Event Description

The event involved a 7" (18 cm) appx 0.24 ml, smallbore ext set w/clave¿, clamp, rotating luer where it was reported that the product did not connect properly to line and leaked patient's blood.The status of the product was during set up and infusion.The set up was, connected to intravenous (iv) catheter cannula, then the extension tubing was connected to iv bag tubing and iv bag.The medications involved were iv saline + vitamin and minerals (vit.C, magnesium, calcium gluconate, b12 etc).It was also reported that the blood loss was not clinically significant and no medical intervention was required, other than replacing the extension tubing.The tubing was replaced twice, and three times had got two faulty ones in a row, needing to open 3 sets on one patient.There was patient involvement, however no report of patient harm.This captures 9 out of 19 occurances.

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/CLAVE¿, 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17510291
• MDR Text Key: 321407069
• Report Number: 9617594-2023-00521
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Public: (01)(17)280501(10)13641832
• 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
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MS933
• Device Lot Number: 13641832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: INTRAVENOUS CATHETER CANNULA, UNK MFR; UNSPECIFIED INTRAVENOUS TUBING, UNK MFR; UNSPECIFIED IV SALINE,VITAMIN,MINERALS BAG,UNK MFR