MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGA; MASK,OYGEN - NON-REBREATHING

Catalog Number 1059

Device Problem Disconnection (1171)

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

Event Date 12/25/2015

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.No photo for review.A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.Customer complaint cannot be confirmed based only on the information reported.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the joint of the mask and tube came off easily.

Manufacturer Narrative

(b)(4).One unit of catalog number 1059 (mask , non-rebreath w/safety vent , elongate) was received for analysis.A visual exam was performed and was it was found that the tube was disconnected from the mask.No residues of pip were found on female adaptor tubing.The device history record (dhr) of lot number 74b1503408 was reviewed and no issues or discrepancies were 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 was confirmed.The female adaptor tubing and the star lumen frosted tubing were detached and no residues of pip were found on the female adaptor tubing.The manufacturing process was reviewed and no similar issues were found related with the sample received, therefore, this is considered to be an isolated event.As a corrective action , personnel from production were notified about this complaint and will be re-trained on the work instruction.

Event Description

The customer alleges that the joint of the mask and tube came off easily.

• Brand Name: HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGA
• Type of Device: MASK,OYGEN - NON-REBREATHING
• 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: 5390965
• MDR Text Key: 37019280
• Report Number: 3004365956-2016-00089
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

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: 1059
• Device Lot Number: 74B1503408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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