MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ EXTENSION SET FILTER; FILTER, INFUSION LINE

Catalog Number MX1483

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

See mfr: 3012307300-2017-01693 (same patient).Potential lot numbers: 3356890 and 3350649.The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that the patient experienced blood loss during use of a medex¿ extension set filter.No permanent injury was reported.

Manufacturer Narrative

Six used medex¿ extension set filters were returned for investigation.One sample was missing the plastic luer covers and male luer lock.Three samples were returned with disconnected male luer locks.One sample was returned with disconnected male and female luer locks.One sample was received with the male luer lock disconnected and attached to an unknown component.Visual examination of the tubing with the disconnected luer locks showed presence of solvent (dried solvent ring around the tubing) in all samples.A simulated manufacturing process was performed and no discrepancies were found.Visual inspection confirmed the complaint, but no root cause was determined.No cause was found related to the manufacturing process.

• Brand Name: MEDEX¿ EXTENSION SET FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; 1 st. crispin way; haslingden; rossendale, lancashire BB4 4 PW; UK BB4 4PW
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6768098
• MDR Text Key: 81847869
• Report Number: 3012307300-2017-01687
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MX1483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 29 MO