MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for HIGH PRESSURE BRAIDED CONNECTING TUBE HPCT8.8-60-P-FM manufactured by Cook Inc.
[119555117]
Product code = dtl. 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
[119555118]
It was reported, while an injector was attached, air bubbles were noted in the high pressure braided connecting tube. This occurred while the physician was manipulating (push and pull) the injector. The lot number was not provided. No patient adverse effect has been reported in conjunction with this event. Additional information regarding product and event details, patient anatomy and outcome has been requested, but is not available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02659 |
| MDR Report Key | 7838537 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-08-31 |
| 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 | MR. LARRY POOL |
| 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 | 0 |
| Brand Name | HIGH PRESSURE BRAIDED CONNECTING TUBE |
| Product Code | GAZ |
| Date Received | 2018-08-31 |
| Catalog Number | HPCT8.8-60-P-FM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-08-31 |