MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TUBING, OXYGEN SUPPLY 7'; PRESSURE TUBING AND ACCESSORIES

Catalog Number 1115

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual inspection of the product involved in the complaint was performed on a picture provided by the customer of connector tfx-000195 (reduced hose end).No issues can be observed that can lead this customer complaint.A dimensional and functional inspection of the device involved in the complaint could not be conducted since the device was not returned.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation and determine the source of the alleged defect, it is necessary to evaluate the device involved on this complaint.However , material from the production line was functionally inspected according to tp-0152 and no issues were detected that can lead this customer complaint.If the device sample becomes available at a later date this complaint will be updated.

Event Description

Customer complaint alleges that the device leaks from the joint between the oxygen tubing and the connector end.Alleged defect detected during use.No harm or injury to patient reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were found.The sample passed the leak test.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigation performed, the reported complaint could not be confirmed.The sample was evaluated and it was not possible to confirm the defect reported by the customer.No leakage was detected.The product was assembled and inspected according to specifications.

Event Description

Customer complaint alleges that the device leaks from the joint between the oxygen tubing and the connector end.Alleged defect detected during use.No harm or injury to patient reported.

• Brand Name: HUDSON TUBING, OXYGEN SUPPLY 7'
• Type of Device: PRESSURE TUBING AND ACCESSORIES
• 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: 6421239
• MDR Text Key: 70522048
• Report Number: 3004365956-2017-00108
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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