MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BITE-GARD ORAL BITE BLOCK,INTL; ENDOSCOPIC BITE BLOCK

Catalog Number 41140

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "one of our hudson rci bitegards broke off at the point where the handle attaches to the actual bite block itself." no patient injury reported.

Manufacturer Narrative

(b)(4).One (1) unit of fg 41140 "bite-gard oral bite block,intl" was received for analysis.Signs of use are observed since a disinfection tag is present and the sample was not received on its original package.While performing the visual inspection to received sample, part of the handle was observed on the bite block which indicates that the damage issue was generated due to an incorrect use of the device.What the customer is reporting as "broke off issue" it is actually damaged on the device.No other issues were found.The lot number provided for this complaint (74l1800079) does not correspond to the product reported by the customer.Corresponds to another teleflex p/n.The customer complaint is confirmed since a broke sample of product code 41140 was received for evaluation.While performing the visual inspection to received sample, part of the handle was observed on the bite block which indicates that the damage issue could have been generated due to an incorrect use of the device.What the customer is reporting as "broke off issue" it is actually a damaged on the device.(see attached pictures).Although the complaint is confirmed based on the sample provided, the customer complaint cannot be confirmed as manufacturing issue.Based on previous statements , it is not possible to establish corrective actions.

Event Description

The complaint is reported as: "one of our hudson rci bitegards broke off at the point where the handle attaches to the actual bite block itself." no patient injury reported.

• Brand Name: HUDSON BITE-GARD ORAL BITE BLOCK,INTL
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8675342
• MDR Text Key: 147210616
• Report Number: 3004365956-2019-00135
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 41140
• Device Lot Number: 74L1800079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1