MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX KITS DISINFECTION; ANESTHESIA CONDUCTION KIT

Catalog Number EPX870/100CJP

Device Problems Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

One portex pain kit was returned for analysis.The stylet was attempted to be inserted into the tuohy needle but resistance was met.Visual inspection of the inside of the needle revealed that there was a substance in the lumen.A syringe was then connected to the hub of the tuohy needle, but no leak was observed.The hub inner diameter conformed to the inspection gauge; no discrepancies noted.Based on the evidence, the complaint was confirmed.It was found that there is a possibility that the substance was of biological origin adhered to the needle lumen after use.It was also presumed that the leakage came from the adapter not being connected securely.

Event Description

Information was received indicating that fluid leaked from the needle base on a smiths medical portex pain management kit during infusion of medical fluid.The leak was noted between the plastic base and the needle.The inner cylinder was attempted to be returned into the needle but was unsuccessful.There was no reported adverse effects.

• Brand Name: PORTEX KITS DISINFECTION
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL JAPAN LTD.,; 627-1 yokouchi, komaki-shi; aichi 485-0081,; JA
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 8777424
• MDR Text Key: 150605382
• Report Number: 3012307300-2019-02992
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EPX870/100CJP
• Device Lot Number: 190221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Date Manufacturer Received: 06/12/2019
• 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: Initial
• Patient Sequence Number: 1