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 2015-02-25 for SINGLE HEATED DUAL LIMB W DRAIN 880-34KIT manufactured by Teleflex Medical.
[21565828]
The customer alleges the circuit was observed to be cracked prior to use on patient. There was no patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
[21813543]
(b)(4). Device history record (dhr) review was performed on the reported lot# and there were no issues related to functional issues neither on the product or components during the manufacturing of the material. The reported complaint cannot be confirmed at this time because the defective sample is currently being investigated. The reported defect is a known issue and is currently being investigated by the manufacturer to determine the root cause of the reported failure. When additional information is provided a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00066 |
| MDR Report Key | 4552867 |
| Report Source | 05,06,07 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-02-02 |
| Date of Event | 2015-01-29 |
| Date Mfgr Received | 2015-02-02 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-03-27 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WARRENDA PETERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193613959 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE HEATED DUAL LIMB W DRAIN |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-02-25 |
| Returned To Mfg | 2015-02-13 |
| Catalog Number | 880-34KIT |
| Lot Number | 74G1401890 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-02-25 |