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

Catalog Number MX9604A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

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 Description

It was reported that during setup of a medex logical single monitoring kit, serum leakage occurred in the valve.It was noted that the device was being set up to carry out a procedure.No injury was reported.

Manufacturer Narrative

The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.One partial used sample was received for device evaluation.Visual inspection found a crack on the trigger flush body.Functional testing, including air leak and water leak detection, was also performed.Both air leak and water leak testing found leakage on the trigger flush body.Based on the results of the investigation, the observed issue was traced to the machine that assembled the kit's trigger flush during the manufacturing process.The investigation determined that the assembly machine had inserted the trigger flush piston with excessive pressure, resulting in the observed cracking.

• Brand Name: MEDEX¿ LOGICAL® SINGLE MONITORING KIT
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING SA DE CV; carretera miguel alemán km21.7; parque industrial monterrey; CP 66 603; MX CP 66603
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6697492
• MDR Text Key: 79504701
• Report Number: 3012307300-2017-01448
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 10351688502933
• UDI-Public: 10351688502933
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K820355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/29/2019
• Device Catalogue Number: MX9604A
• Device Lot Number: 3256554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1