MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC,ELONG,ADULT; MASK, OXYGEN

Catalog Number 1041

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.The device history record (dhr) of batch number reported has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Additionally, material from the production line was verified and no issues were found that can lead this customer complaint.Customer complaint cannot be confirmed based only on the information provided.To perform a proper and thorough investigation, it is necessary to evaluate the sample involved.It is noted that based on complaint trending, a capa request was initiated in order to further investigate this same issue.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the device tubing came disconnected during use on a patient.There was no report of patient complication or medical intervention.Patient condition reported as fine.It was reported that an alternative product was used to resolve the issue.

Event Description

Customer complaint alleges the device tubing came disconnected during use on a patient.There was no report of patient complication or medical intervention.Patient condition reported as fine.(continued) it was reported that an alternative product was used to resolve the issue.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and while performing the visual inspection it was observed that the female adaptor easily disconnects from the grommet.The female adaptor tubing and was measured and was found to be within dimensional specifications.Based on the investigation performed the complaint was confirmed.Although the complaint was confirmed, there is not sufficient evidence to assure this issue was originated during the manufacturing process.A dimensional inspection test was performed and no dimensional issues were found.Due to customer complaint trending a capa request was initiated to further investigate this issue.

• Brand Name: HUDSON MASK,MEDIUM CONC,ELONG,ADULT
• Type of Device: MASK, OXYGEN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8461259
• MDR Text Key: 140291616
• Report Number: 3004365956-2019-00088
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/25/2023
• Device Catalogue Number: 1041
• Device Lot Number: 74F1801790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.