MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL

Catalog Number 403128

Device Problems Kinked (1339); Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned for evaluation.The device history record review showed that there were no issues related to functional issues neither on the product nor its components during the manufacture of the material.Customer complaint cannot be confirmed, based on the lack of device sample.The physical sample is necessary in order to perform a proper investigation.If the device sample becomes available this complaint will be re-opened.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code (403128; adaptor, 028 neb, (b)(4)) available at the facility.However regarding other customer complaints from this same issue, a capa file #(b)(4) was opened to perform a further investigation this issue.

Event Description

The customer alleges that the adaptor does not fit the flowmeter properly and the tubing seems softer and kinks.No patient injury reported.

• Brand Name: HUDSON ADAPTOR,028 NEB,INTL
• Type of Device: ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5087389
• MDR Text Key: 26439143
• Report Number: 3004365956-2015-00289
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/26/2020
• Device Catalogue Number: 403128
• Device Lot Number: 74B1503149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2015
• 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