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

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).A visual inspection of the device involved in the complaint was performed on a picture provided by the customer.However this picture is not clear enough to confirm this customer complaint.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned at the time of this report.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.Visual inspection of the product involved in the complaint was performed on a picture provided by the customer and it is not clear enough to confirm this customer complaint.To perform a proper investigation, and determine the source of the alleged defect reported, it is necessary to evaluate the sample involved in this complaint.However material from the production line was verified and no issues were found that can lead this customer complaint.If the device sample becomes available at a later date, this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges "believes they are having issues with carefusion or teleflex products depositing shards of plastic in the circuits".Alleged defect reported as detected during use.It was reported there was no patient injury or necessary medical intervention.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was damage on the adaptor.Based on the visual exam the complaint was confirmed.The dhr 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.Although the complaint is confirmed based on the sample received there is not sufficient evidence to assure this issue was originated during the manufacturing process.The root cause for the condition reported could not be identified.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.

Event Description

Customer complaint alleges "believes they are having issues with carefusion or teleflex products depositing shards of plastic in the circuits".Alleged defect reported as detected during use.It was reported there was no patient injury or necessary medical intervention.

• Brand Name: HUDSON ADAPTOR,CUFF,22MM ID
• Type of Device: CONNECTOR, AIRWAY
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6594092
• MDR Text Key: 76199292
• Report Number: 3004365956-2017-00221
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

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: 1421
• Device Lot Number: 74C1700287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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