MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS MULTI LINE WITH FILTER; FILTER, INFUSION LINE

Model Number	MX448HFB
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was connected to 1l bolus of normal saline in hallway bed across from nurse's station.While infusing, defective iv tubing broke in half about 5 inches from hub connection to the patient.Fluid leaked out onto floor and blood into tubing still connected to patient.Break was noticed immediately and tubing was disconnected.Fluids cleaned up and properly and disposed of.No harm to patient, iv catheter undamaged and remained intact.
Additional Manufacturer Narrative
Device lot number, manufacture, and expiration dates are unknown, no product 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 required.
Additional Manufacturer Narrative
Other, other text: h3.Device evaluated by manufacturer and h6.Event problem and evaluation codes: updated.The complaint could not be confirmed as no sample was provided by the customer.With no product returned in this case, the causal factor of the reported issue cannot be established.A device history record (dhr) review could not be performed as the lot number of the device is unknown.If the product is returned the investigation will be reopened.

• Brand Name: MEDEX EXTENSION SETS MULTI LINE WITH FILTER
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16186544
• Report Number: 3012307300-2023-00520
• Device Sequence Number: 2633564
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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 Model Number: MX448HFB
• Device Catalogue Number: MX448HFB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 03/09/2023
• 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
• Patient Sex: Unknown