MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PAIN MANAGEMENT KIT; ANESTHESIA CONDUCTION KIT

Catalog Number 915/018/0002/PJJP

Device Problems Break (1069); Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Lot expiration and create date for this device are not available at this time.Report source foreign: (b)(6).Device evaluation: one flat filter and epifuse connector was returned for investigation.Immediate visual inspection detected that the flat filer was not passed and the epifuse connector was locked.A stock catheter was connected to the flat filter and epifuse connector to test for a leak, but no leakage was found.In addition, the inner and outer diameters of each connector were checked using an inspection gauge, but all the connectors were found to have conformed to the standard, and no abnormalities were found.Additionally, 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.Based on the evaluation and testing, the complaint was not confirmed.No fault was found with the returned sample.

Event Description

Information was received that a smiths medical portex pain management kit leaked medical fluid from the epidural filter immediately on use.There were no adverse patient effects.

• Brand Name: PORTEX PAIN MANAGEMENT KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL JAPAN LTD; komaki facilities; 627-1 yokouchi komaki-shi; aichi, ; JA
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9527423
• MDR Text Key: 176479641
• Report Number: 3012307300-2019-07468
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 915/018/0002/PJJP
• Device Lot Number: 190702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 12/02/2019
• 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