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 2016-03-30 for HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONG 1059 manufactured by Teleflex Medical.
[41472545]
(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned for evaluation. No photo available for evaluation. The device history record of batch number 74f1500091 that belong to catalog number 1059 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. No non conformance reports were originated for the lot in question that can be associated to the complaint reported. Dhr shows that the product was assembled and inspected according to our specifications. Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint. However material from the production line was inspected and no issues were detected that can lead to this customer complaint. If the device sample becomes available at a later date this complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
[41472546]
The customer alleges that the bag burst using a flow rate of 9l/min. The thermo welding cracked on the upper portion of the pocket at the mask connection. No clinical consequence.
Patient Sequence No: 1, Text Type: D, B5
[43654503]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the reservoir bag was burst. The sample evaluated confirms the reported defect; the reservoir bag was burst. The production line was reviewed to possibly identify any situation that could cause the bursting, and no issues were found. Complaint history was reviewed and there were no issues similar to this reported in the past, indicating that this is an isolated event. All personal from the production line will be notified of this issue. 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
[43654504]
The customer alleges that the bag burst using a flow rate of 9l/min. The thermo welding cracked on the upper portion of the pocket at the mask connection. No clinical consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00165 |
| MDR Report Key | 5535481 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-16 |
| Date of Event | 2016-03-15 |
| Date Mfgr Received | 2016-04-22 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2016-03-30 |
| 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 MASK,NON-REBREATH W/SAFETY VENT,ELONG |
| Generic Name | MASK, OXYGEN, NON- REBREATHING |
| Product Code | KGB |
| Date Received | 2016-03-30 |
| Returned To Mfg | 2016-03-28 |
| Catalog Number | 1059 |
| Lot Number | 74F1500091 |
| 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 | 2016-03-30 |