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

Model Number FS116

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

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 (b)(6) 2021 to supplier (b)(4).

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 (b)(6) 2021 to supplier (b)(4).

Event 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
• Type of Device: 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: 13549589
• MDR Text Key: 285757964
• Report Number: 3012307300-2022-03547
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 10351688510969
• UDI-Public: 10351688510969
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1