MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ LOGICAL® 3 GANG MANIFOLD; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	M20178R2
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that the high pressure tubing of a medex logical 3 gang manifold was not bonded on the proper side of the manifold.No injury was reported.
Additional Manufacturer Narrative
Two photos and one used medex¿ logical® 3 gang manifold were returned for investigation.Visual inspection confirmed the complaint was the part was identified being connected to the wrong port, tubing subassembly was bonded to the wrong side.The root cause was determined to be manufacturing; the defect is associated to a process assembly that is totally manual.The only support for the operator is a drawing, which can lead to a mistaken port selection.

• Brand Name: MEDEX¿ LOGICAL® 3 GANG MANIFOLD
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6690876
• Report Number: 3012307300-2017-01427
• Device Sequence Number: 16615015
• Product Code: DRS
• UDI-Device Identifier: 10351688510785
• UDI-Public: 10351688510785
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K820355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: No Information
• Device Expiration Date: 05/28/2019
• Device Catalogue Number: M20178R2
• Device Lot Number: 3211656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1