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

Catalog Number 1059

Device Problems Burst Container or Vessel (1074); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2016

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 for evaluation.No photo available for evaluation.The device history record of batch number 74f1500091 that belong to catalog number 1059 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.However material from the production line was inspected and no issues were detected that can lead to this customer complaint.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the bag burst using a flow rate of 9l/min.The thermo welding cracked on the upper portion of the pocket at the mask connection.No clinical consequence.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the reservoir bag was burst.The sample evaluated confirms the reported defect; the reservoir bag was burst.The production line was reviewed to possibly identify any situation that could cause the bursting, and no issues were found.Complaint history was reviewed and there were no issues similar to this reported in the past, indicating that this is an isolated event.All personal from the production line will be notified of this issue.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

The customer alleges that the bag burst using a flow rate of 9l/min.The thermo welding cracked on the upper portion of the pocket at the mask connection.No clinical consequence.

• Brand Name: HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONG
• Type of Device: MASK, OXYGEN, 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: 5535481
• MDR Text Key: 41472545
• Report Number: 3004365956-2016-00165
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/16/2016

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: 74F1500091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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