MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SET; TUBING, FLUID DELIVERY

Model Number	MX451FL
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
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: no patient injury reported.
Additional Manufacturer Narrative
Additional information: b5, h6 and h10 this mdr was generated under protocol b10010116, as a result of warning letter cms#(b)(4).No problems or issues were identified during the device history record review.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Action taken: review of the maintenance work order history during and around the time of the reported event showed during this production run, two work orders were written.Work order was written with a description that indicated that no solvent was being applied to the tubing on the male end of the set on 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.A work order 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 for the 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.Any maintenance work order that is related to correction of solvent application is 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 ncmr 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.A review of the last two years of complaints shows 5 sets of complaints that come to a quantity of 14 components that have experienced this defect.Two lots have been identified, all other complaints have been "unknown lots"., corrected data: correction to: b1 and h1.

• Brand Name: MEDEX EXTENSION SET
• Common Device Name: TUBING, FLUID DELIVERY
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11896122
• Report Number: 3012307300-2021-05202
• Device Sequence Number: 11109631
• Product Code: FPK
• 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): 05/30/2023

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: 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: 05/02/2023
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown