MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX PRESSURE MONITORING TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX560
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: b3: date of event, d4: lot number, expiration date, e1: reporter address, city, state, zip code, phone number, g5: 510k and h4: manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the registered nurse noticed that blood was backing up in catheter tubing.It was then noticed that blood was dripping from the tubing.While doing the alcohol scrub, the tubing fell apart ("broke in at end, near connection").Adverse effects have not been reported.
Additional Manufacturer Narrative
One device was returned for investigation.The component was in good condition and both connectors were found fully attached.The component was water leak tested per internal specifications and passed.The described defects could not be replicated, and the complaint cannot be confirmed.The root cause for this event is unknown.Complaint data for the device was reviewed and one other complaint was found for connectors becoming detached, but no other complaints were found for the device leaking.No lot number was provided to review a device history record.Manufacturer will continue to track and trend complaints and escalate as needed.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: MEDEX PRESSURE MONITORING TUBING
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18075113
• Report Number: 3012307300-2023-10249
• Device Sequence Number: 12661082
• Product Code: FPA
• UDI-Device Identifier: 10351688506597
• UDI-Public: 10351688506597
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown