MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,040 HUM,INTL

Catalog Number 400040

Device Problems Break (1069); Connection Problem (2900)

Patient Problem 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 received at our facility.The device history record showed that there were no issues related to functional issues on the molded component involved in this complaint during the manufacture of the material.Regarding this issue a capa file #(b)(4) was opened.According to the capa investigation so far the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.Customer complaint cannot be confirmed, based only on the information provided, to perform a correct investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code (400040; adaptor ,040 hum,intl) available at the facility nor is being manufactured at the time; however regarding other customer complaints for this same issue, a capa file #(b)(4) was opened to perform a further investigation.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the adaptor does not fit properly to the flow meter.The adaptor broke.

• Brand Name: HUDSON ADAPTOR,040 HUM,INTL
• Type of Device: ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5104399
• MDR Text Key: 26910719
• Report Number: 1417411-2015-00146
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 400040
• Device Lot Number: 03D15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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