MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2010-10-07 for HUDSON NON-REBREATHING MASK W/ SAFETY VENT 1059 manufactured by Teleflex Medical.
[1836872]
The event is reported as: the reservoir bag came off after less than 24 hours of use. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8892302]
The device sample was sent to the mfg site for eval. The results of the investigation are from photos and testing of stock product. Eval: method: device history record review. Results: device history record review - lot number unk but lot# 02j1001357 was substituted for review. No issues were found in the review. Pull and heat testing done and compared to photos provided by customer. Some similar condition was observed when compared to the photos. Results: the green tape used to hold the breathing bag is shorter than usual. Conclusions - complaint confirmed. Root causes: heat, flow and green tape length. The mfg team modified the set-up procedure used to set the length of the green tape dispenser. Also, a visual help with the length will be created and this will be used to adjust the green tape dispense green tape length will be created.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2010-00289 |
| MDR Report Key | 1881406 |
| Report Source | 01,06,08 |
| Date Received | 2010-10-07 |
| Date of Report | 2010-09-17 |
| Date of Event | 2010-07-28 |
| Date Mfgr Received | 2010-09-17 |
| Date Added to Maude | 2010-11-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TAGGART, VP |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334916 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON NON-REBREATHING MASK W/ SAFETY VENT |
| Generic Name | NON-REBREATHING MASK |
| Product Code | CBP |
| Date Received | 2010-10-07 |
| Returned To Mfg | 2010-09-27 |
| Model Number | NA |
| Catalog Number | 1059 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-07 |