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 2016-02-12 for HUDSON BITE-GARD ORAL BITE BLOCK,INTL 41140 manufactured by Teleflex Medical.
[38096918]
(b)(4) a conclusion code could not be chosen. The complaint was confirmed via photo inspection; however, a root cause could not be identified. Customer complaint is confirmed since a picture of product code 41140 (bite-gard oral bite block,intl) was received for evaluation (handle and block are separated). While performing the visual inspection test on the received picture, part of the handle was observed on the bite block which indicates that it was bonded correctly. Also a wear on the handle was observed which could be related to a correct bonding of the bite block. A dimensional and functional inspection of the product involved in the complaint could be conducted since the device was not returned. The device history record of (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. Dhr shows that the product was assembled & inspected according to our specifications. Based on picture of product 41140 "bite-gard oral bite block, intl. " provided by the customer, a disconnection between the handle and the bite block is confirmed, however based on the picture it is not possible to determine that the issue was caused by an inappropriate assembly (bonding). Other remarks: as part of the investigation, dhr was revised observing that this specific lot required an average of 64. 7lbs of force to disconnect both components. Additionally process was audited per actions established on capa#(b)(4) open for this same issue, without any findings. Sample is required in order to perform a detailed analysis of the part to try to determine the root cause of the issue.
Patient Sequence No: 1, Text Type: N, H10
[38096919]
The customer alleges that the bite block separated and was in the patient's airway. The customer reports no harm to the patient. Intervention - the patient received brief anesthesia to retrieve the bite block.
Patient Sequence No: 1, Text Type: D, B5
[41230922]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the bite block and the handle were disconnected. It was also observed that the bite block was bonded correctly. Based on the sample received, a disconnection between the handle and the bite block is confirmed. Although the complaint is confirmed, a root cause for the issue could not be determined. As part of the investigation, the dhr was revised observing that this specific lot required an average of (b)(6) lbs of force to disconnect both components. Additionally process was audited per actions established on (b)(4) open for this same issue, without any findings. A conclusion code could not be chosen as the complaint was confirmed; however, a root cause for the reported issue could not be established.
Patient Sequence No: 1, Text Type: N, H10
[41230923]
The customer alleges that the bite block separated and was in the patient's airway. The customer reports no harm to the patient. Intervention - the patient received brief anesthesia to retrieve the bite block.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00118 |
| MDR Report Key | 5433484 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-02-12 |
| Date of Report | 2016-01-29 |
| Date of Event | 2016-01-28 |
| Date Mfgr Received | 2016-03-18 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2016-02-12 |
| 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 GARD |
| Product Code | MNK |
| Date Received | 2016-02-12 |
| Returned To Mfg | 2016-02-08 |
| Catalog Number | 41140 |
| Lot Number | 74E1400379 |
| 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 | 1. Required No Informationntervention | 2016-02-12 |