MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-01-06 for HUDSON SINGLE HEATED DUAL LIMB W DRAIN 880-34KIT manufactured by Teleflex Medical.
[21839123]
The customer alleges that the circuit has a split in the seam. The tech noticed this alleged defect before installing on the ventilator. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[21848188]
(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00012 |
| MDR Report Key | 4398549 |
| Report Source | 05,06,07 |
| Date Received | 2015-01-06 |
| Date of Report | 2014-12-10 |
| Date of Event | 2014-12-09 |
| Date Mfgr Received | 2014-12-10 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-01-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD. |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| 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 SINGLE HEATED DUAL LIMB W DRAIN |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-01-06 |
| Catalog Number | 880-34KIT |
| Lot Number | 74G1401890 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-06 |