MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-09-09 for HUDSON BITE-GARD ORAL BITE BLOCK,INTL 41140 manufactured by Teleflex Medical.
[25340806]
(b)(4). The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report. Two pictures of catalog number 41140 (bite-gard oral bite block, intl) were received for analysis. During the visual inspection it can be observed the component part number 10752 handle, oral bite block is detached from component part number 10707 bite block, large. No other issues were found. The device history record review showed that there were no issues related to this complaint neither on the product nor its components during the manufacture of the material. During the visual inspection on the received pictures it was observed that the handle was detached out from the bite block. Also, it was observed residues of the bite block on the handle.
Patient Sequence No: 1, Text Type: N, H10
[25340807]
The customer alleges that the bite block was placed in the patient's mouth due to the patient biting the endotracheal tube. Soon after placement, the bite block completely fell apart and the patient had bitten through the main body of the bite block. All parts were removed from the patient's mouth. The patient's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[27479121]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the bite block was damaged. Based on the visual exam, the reported complaint is confirmed. The device history record of batch number 74e1400379 has been reviewed and no issues or discrepancies were found which could be potentially related to the complaint. No non-conformance reports were originated for the lot in question. Dhr shows that the product was assembled and inspected according to specifications. The last dhr of component (b)(4) was reviewed to verify the process parameters and used material and no issues or discrepancies were found which could potentially relate to this issue. No corrective action can be implemented since the failure mode is not related to the manufacturing process of the product. A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
[27479122]
The customer alleges that the bite block was placed in the patient's mouth due to the patient biting the endotracheal tube. Soon after placement, the bite block completely fell apart and the patient had bitten through the main body of the bite block. All parts were removed from the patient's mouth. The patient's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00277 |
| MDR Report Key | 5065036 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-09-09 |
| Date of Report | 2015-08-19 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2015-09-24 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON BITE-GARD ORAL BITE BLOCK,INTL |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2015-09-09 |
| Returned To Mfg | 2015-09-04 |
| Catalog Number | 41140 |
| Lot Number | 74E1400379 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-09 |