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

Model Number	MX448F78MG
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical extension set was leaking during use with iv fluid with nicu patients.There were no reported adverse events.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Twenty-nine (29) samples were received from customer.Water/leak test: returned samples were inspected for water leak test at 20 psi for 30 sec according to procedure mty-qc001 rev.102 and mty-m-5 rev.101 and mty-m-181 rev.102.Results: 6 out of 29 samples presented leak at the solvent bonding of stopcock p/n a409g2 and male luer lock p/n 500-010.Visual inspection was executed by un-aided eye and under magnification.Results: components shows a leak channel due to a lack of solvent during bonding process.Based on visual inspection of the samples, the most likely cause is a lack of solvent during rigid-rigid bonding process.Actions - awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held, documented on folio (b)(4) completed on 02/jun/21.As part of improvement activities solvent dispensers were identified with the expected level of solvent to avoid lack of solvent in the dip.Completed on 23/jun/21.Complaint data was reviewed on 14/july/2021 and after reviewing the complaints history from june 2018 to date, it was found that these are the 3rd.To 8th.Complaint related to leaking defect on the reported code: mx448f78mg.Previous complaints (b)(4) were not confirmed since no product was returned for investigation.No discrepancies were observed during the manufacturing of this lot.The cause of the reported problem was traced to the manufacturing process.

• Brand Name: MEDEX
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12019650
• Report Number: 3012307300-2021-06201
• Device Sequence Number: 1376441
• Product Code: FPA
• UDI-Device Identifier: 10351688518842
• UDI-Public: 10351688518842
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MX448F78MG
• Device Lot Number: 4079669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• 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: 05/20/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown