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

Catalog Number	MX9604A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that serum was leaking after filling a medex¿ logical® pressure monitoring set.There was no patient involvement; the problem was identified after assembly.
Additional Manufacturer Narrative
Upon receipt of the returned product sample, it was visually examined.One used partial single pressure monitoring kit was received.Visual inspection found a tear in the diaphragm of the dome.Functional testing was performed to test for air and water leakage.Air and water leak testing revealed a leak on the diaphragm.A review of the device history record found no discrepancies with relation to the reported issue.Sample testing from three lots, including one sample from this lot, was performed.This testing revealed no defects or anomalies.Prior to release for distribution of the respective lot for the returned sample, parts from this lot were 100 percent air leak tested.The root cause has been attributed to damage observed on the diaphragm, which likely occurred during use.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: MEDEX¿ LOGICAL® PRESSURE MONITORING SET
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6732343
• Report Number: 3012307300-2017-01557
• Device Sequence Number: 821581
• Product Code: DRS
• UDI-Device Identifier: 10351688502933
• UDI-Public: 10351688502933
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K820355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: 08/22/2019
• Device Catalogue Number: MX9604A
• Device Lot Number: 3248616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1