MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-05 for MEDIUM PRESSURE CONNECTING TUBE G00040 DPT9.5-180-P-FM manufactured by Cook Inc.
[176799004]
Per the initial reporter, it is unknown if the device will be returned. Common name & product code = dtl adaptor, stopcock, manifold, fitting, cardiopulmonary bypass. (b)(6). Pma/510(k) number = exempt. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[176799005]
As reported, during a procedure involving placement of an aortic stent, a medium pressure connecting tube split. The tubing was connected and used at 750 psi at which time it split and sprayed the sterile field and occupants with contrast. Two other devices of the same type malfunctioned in the same manner during the procedure. These events are reported under patient identifiers (b)(6) and (b)(6); although they involve the same patient and same procedure. A fourth device of the same type was used to complete the procedure. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02789 |
| MDR Report Key | 9280650 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-05 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-08-08 |
| Date Added to Maude | 2019-11-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIUM PRESSURE CONNECTING TUBE |
| Product Code | DTL |
| Date Received | 2019-11-05 |
| Model Number | G00040 |
| Catalog Number | DPT9.5-180-P-FM |
| Lot Number | 9937490 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-05 |