MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 84" (213 CM) 10 DROP, VENTED/NON-VENTED GRAVITY ADMIN SET W/PRE-SLIT PORT, MICRO; STOPCOCK, I.V. SET

Model Number MRSA10-84

Device Problem Particulates (1451)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

The incident involved a 84" (213 cm) 10 drop, vented/non-vented gravity admin set with pre-slit port, microclave¿ clear, rotating luer, approximate priming volume: 10.5 ml.The customer reported that there was an anecdotal incident regarding debris in the tubing on an unknown date that had been talked about but not previously reported.There was unknown patient involvement and unknown patient harm.

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Additional contact: (b)(6).

• Brand Name: 84" (213 CM) 10 DROP, VENTED/NON-VENTED GRAVITY ADMIN SET W/PRE-SLIT PORT, MICRO
• 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: 16378635
• MDR Text Key: 309612281
• Report Number: 9617594-2023-00079
• Device Sequence Number: 1
• Product Code: FMG
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MRSA10-84
• Device Catalogue Number: MRSA10-84
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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