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

Model Number	MX451FL
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a smiths medical extension set came apart at the distal portion suddenly and blood was flowing everywhere.Then patient bleeding everywhere due to the disconnection of the distal part of the tubing.There were no other adverse events reported.
Event or Problem Description
Additional information received 29-june-2021: no patient injury.
Additional Manufacturer Narrative
No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.Maintenance work order history was reviewed during and around the time the lot reported was manufactured.The lot was produced between 03-feb-2021 and 05-feb-2021; during this production run, two work orders were written.Work order (wo) was written with a description that indicated that no solvent was being applied to the tubing on the male end of the set on 03-feb-2021 1st shift.The root cause was found to be that the drop needle that applies the solvent had bent enough that intermittent tubing sets were not receiving the solvent.The correction was to replace the bent needle.Wo was written with a description that also indicated that no solvent was being applied to the tubing on the male end of the tubing set on 04-feb-2021 2nd shift.The root cause was that the bolt that controls the drop needle adjustment was loose and allowed the needle to move.The correction was to place the needle back and tighten the bolt.Per procedures, any maintenance work order that was related to correction of solvent application was to have samples ran after correction and given to qc for further testing and confirmation of correction.It does not appear that this was completed based on the work order documentation.The technician identified has been notified and will re-train to this procedure to ensure that solvent application corrections follow this procedure.On top of this re-training it has been decided that with any solvent application work orders an associated shall be written by production to flag the lot for 100% solvent inspection (missing component).Quality alerts have been posted on the production machine and notifications have been sent to all production management and supervision.(b)(4).Two lots have been identified, all other complaints have been "unknown lots".

• Brand Name: MEDEX 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; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11895943
• Report Number: 3012307300-2021-05191
• Device Sequence Number: 14817319
• Product Code: FPA
• UDI-Device Identifier: 10351688507310
• UDI-Public: 10351688507310
• 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): 05/10/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MX451FL
• Device Catalogue Number: MX451FL
• Device Lot Number: 4098130
• Was Device Available for Evaluation?: No
• 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: 04/28/2021
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 05/10/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown