MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. PORTEX 15MM REUSABLE SWIVEL CONNECTOR

Catalog Number 100/250/001

Device Problems Air Leak (1008); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received stating that the listed device was in use with a pt for an unk amount of time when the connector was found leaking.The clinician increased oxygen flow to the pt to compensate for the leakage.There were no adverse effects to the pt reported.

Manufacturer Narrative

Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated the mfr will file a follow-up report detailing the results of the eval.

• Brand Name: PORTEX 15MM REUSABLE SWIVEL CONNECTOR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; hythe, kent ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTL LTD; boundry rd; hythe kent ; UK
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4230543
• MDR Text Key: 4996600
• Report Number: 2183502-2014-00755
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: 100/250/001
• Device Lot Number: 2500402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1