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 2010-04-02 for PLUREVAC THORACIC TROCAR CATH 20FR SOFT 10/BX DTRC-20S manufactured by Teleflex Medical.
[20743807]
The event is reported as: per maude report: attempt to place #20 trocar chest tube twice, product tip would not allow surgeon to successfully place tube. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[20970644]
A device history record (dhr) review could not be conducted since the lot number was not provided. No corrective action can be established since no sample was provided, lot number is not available for a deeper investigation. Complaint cannot be confirmed since no evidence could be gathered in order to evaluate this incident, lot number of the involved product could not be provided either.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2012-00138 |
| MDR Report Key | 2546837 |
| Report Source | 05,06,07 |
| Date Received | 2010-04-02 |
| Date of Report | 2012-03-13 |
| Date of Event | 2012-02-03 |
| Date Mfgr Received | 2012-03-19 |
| Date Added to Maude | 2012-05-04 |
| 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 | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. TRANSFORMACION 5954 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 | PLUREVAC THORACIC TROCAR CATH 20FR SOFT 10/BX |
| Generic Name | CATHETER |
| Product Code | GCD |
| Date Received | 2010-04-02 |
| Catalog Number | DTRC-20S |
| Lot Number | 024102039 |
| Operator | HEALTH PROFESSIONAL |
| 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 | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-02 |