MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-06 for HUDSON TRACH ADAPTOR 2415-01 manufactured by Teleflex Medical.
[64067409]
(b)(4). The investigation into this complaint is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[64067410]
Customer complaint alleges "tubing on the cannula has holes. " alleged defect detected during use. No harm or injury to the patient. Patient condition reported as "fine. "
Patient Sequence No: 1, Text Type: D, B5
[68135600]
Qn#(b)(4). A device history record (dhr) review could not be performed as the lot number was unknown. The actual sample was not returned for evaluation; therefore, the complaint could not be confirmed. In the current manufacturing procedure, 100% leak testing is conducted at the assembly area; therefore, a defect of this type would be detected prior to release. Ten samples were selected from current production at the manufacturing facility and inspected. No defects were found on the samples. They all passed a visual exam and leak testing. If the sample is returned, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
[68135601]
Customer complaint alleges "tubing on the cannula has holes. " alleged defect detected during use. No harm or injury to the patient. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2017-00020 |
| MDR Report Key | 6229500 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2017-02-16 |
| Date Added to Maude | 2017-01-06 |
| 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 | RESPIRATORY THERAPIST |
| 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 | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON TRACH ADAPTOR |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2017-01-06 |
| Catalog Number | 2415-01 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-06 |