MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-31 for HUDSON MASK,MULTI-VENT,ADULT 1088 manufactured by Teleflex Medical.
[91318524]
(b)(4). The physical device sample has not been received by the manufacturer at the time of this report. A visual inspection of the product involved in the complaint was performed on pictures provided by the customer. It can be observed a foreign particle that looks like an insect inside the tubing, and also. No other issues were found. The dhr reviewed showed that there were no issues related to the reported failure mode neither on the product nor its components during the manufacture of this material. Customer complaint is confirmed based on the visual inspection performed to the pictures provided by the customer. However, it is not possible to determine where on the distribution chain of the product the insect got inside the tubing. Although the complaint is confirmed, there is not sufficient evidence that this issue originated during the manufacturing process. The root cause for the condition reported could not be identified. Teleflex (b)(4) has pest control system to avoid contamination by insects in our products. A conclusion code could not be found as the complaint was confirmed but a root cause is unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
[91318525]
Customer complaint alleges "before using the product, a customer found something that looked like a worm in the line of the product. " customer submitted photos for review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00376 |
| MDR Report Key | 6990305 |
| Date Received | 2017-10-31 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-10-23 |
| Date Mfgr Received | 2017-10-23 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2017-10-31 |
| 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 | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| 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 | 0 |
| Brand Name | HUDSON MASK,MULTI-VENT,ADULT |
| Generic Name | MASK, OXYGEN, LOW CONCENTRATIO |
| Product Code | BYF |
| Date Received | 2017-10-31 |
| Catalog Number | 1088 |
| Lot Number | 74C1700492 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-31 |