MAUDE Adverse Event Report: TELEFLEX MEDICAL ADAPTOR,CUFF,22MM ID; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 1421

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection of the product involved in the complaint was performed on the returned sample.It is noted that the product was not received in its original packaging.It can be observed a damage issue on the adaptor.No other issues were found.A device history record review showed that there were no issues related to the reported failure mode, neither on the product nor its components, during the manufacture of this material.Customer complaint is confirmed based on sample provided.However, there is not sufficient evidence to determine this issue originated during manufacturing process.The root cause for the condition reported could not be identified.No corrective actions can be assigned.A conclusion code could not be assigned.The complaint is confirmed but the root cause could not be identified.Teleflex will continue to monitor and trend for reports of this issue.

Event Description

Customer complaint alleges they "are having issues with carefusion or teleflex products depositing shards of plastic in the circuits." alleged defect noted during use.No patient harm reported.

• Brand Name: ADAPTOR,CUFF,22MM ID
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6848466
• MDR Text Key: 85130554
• Report Number: 3004365956-2017-00336
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1421
• Device Lot Number: 74M1602188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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
• Treatment: UNKNOWN CAREFUSION DEVICE