MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX MICRO BORE SINGLE LINE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	536040
Medical Device Problem Codes	Disconnection (1171); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other, other text: d4: lot number, expiration date 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 lipid tubing broke apart during picc dressing change.This required an alteration in fluids given.It is unknown if there was patient harm; "an open fluid pathway increases risks for catheter associated blood stream infection".
Additional Manufacturer Narrative
Other, other text: additional information is provided in d.10., h.2., h.3., and h.6.The product was not returned, as a result the product evaluation and problem confirmation cannot be performed.No part number or lot number was provided with the complaint.Investigation of the device has determined that this product was not made at the manufacturer.The root cause for this event is unknown.For all enquiries or follow-up questions related to the record, do not use egulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: MEDEX MICRO BORE SINGLE LINE EXTENSION SET
• 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: 17761384
• Report Number: 3012307300-2023-08979
• Device Sequence Number: 17808543
• Product Code: FPA
• UDI-Device Identifier: 10351688516336
• UDI-Public: 10351688516336
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K831087
• 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): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 536040
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/06/2023
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 DA
• Patient Sex: Female