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

Model Number	FS116
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to smiths medical.A sample was test for leakage by manually introducing water using a syringe.The sample present leakage by one of the side of the filter.It was observed that the filter is open in one side where should be welded.It present damaged which may indicate a wrong handling of the part.Dhr review was executed and no discrepancies were observed during the manufacturing of reports lot 4068818.The lot used of filter p1123-07 was 6447/20, no defects were reported on this lot of filter.Complaint is confirmed due to sample return present leakage at filter, however root cause is not attributable to manufacturing.Supplier notification was issued on 29-jun-21 to supplier borla.
Event or Problem Description
It was reported that the picu has had "7-8+" occurrences of cracked/leaking filters from the same lot, so 9 files created.No patient injury was reported.

• Brand Name: MEDEX MICRO BORE EXTENSION SETS
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13535607
• Report Number: 3012307300-2022-03402
• Device Sequence Number: 4063389
• Product Code: FPB
• UDI-Device Identifier: 10351688510969
• UDI-Public: 10351688510969
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: FS116
• Device Catalogue Number: FS116
• Device Lot Number: 4068818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown