MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for HUDSON SUBASSY,SHER-I-BRONCH ACCESSORY PACK 02634-01 manufactured by Teleflex Medical.
[134346884]
Qn# (b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned. A device history record investigation did not show issues related to this complaint. A record assessment (fmea) was conducted and no update is required. It is necessary to receive the physical sample to perform a proper and thorough investigation to confirm the alleged defect. Customer complaint cannot be confirmed. Root cause cannot be determined. Corrective actions cannot be assigned. It is unclear if the device is available. Teleflex has requested this information. If the device sample becomes available, this report will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[134346885]
Customer complaint states: "the swivel connector for the sheridan double-lumen tube system sheared off at connecting piece and was unable to be reattached. Alternate adaptor immediately used as replacement. No harm to patient".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2019-00085 |
| MDR Report Key | 8281655 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2018-06-13 |
| Date Added to Maude | 2019-01-28 |
| 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 | 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 | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUDSON SUBASSY,SHER-I-BRONCH ACCESSORY PACK |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2019-01-28 |
| Catalog Number | 02634-01 |
| Lot Number | 73F1800320 |
| Device Availability | N |
| 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 | 2019-01-28 |