MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-15 for RING DRAINAGE CATHETER NEEDLE SET N/A DLPN-40-25-RING manufactured by Cook Inc.
[187453502]
Patient born in (b)(6). Occupation: supervisor. Initial reporter also sent report to fda: unknown. Pma/510(k) #: preamendment. 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
[187453503]
It was reported an african-american patient, unknown gender or exact age, required a ring drainage catheter needle set during a trans-vaginal procedure to drain a vaginal abscess and hematoma. The operator advanced the entire device, then removed the stylet and placed wire through the needle and catheter and pulled 'yellow' catheter off. It was during this maneuver that the operator stated he "felt tension" and "the hub broke loose and completely detached. " upon removal of the catheter, the operator then noticed approximately 1-2cm of the catheter tip was missing. Under fluoroscopy, the operator confirmed the tip was retained inside the abscess. The operator made several attempts to retrieve the catheter tip from the patient. The operator attempted to use unspecified cook vascular retrieval forceps and a snare device from another manufacturer. It was reported due to acute angles within the anatomy, the operator was unsuccessful at retrieving the catheter tip. The location of the catheter tip was marked with an 8. 5fr dawson- mueller drainage catheter. Patient was subsequently taken to the operating suite. A laparoscopic procedure was performed by another operator and catheter tip was removed successfully. No other adverse effects were reported for this incident. The catheter tip separation is recorded under the medwatch report with patient identifier (b)(6). The hub detachment will be captured under medwatch report with patient identifier (b)(6) (this report).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02893 |
| MDR Report Key | 9328362 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-11-15 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-11-06 |
| Date Mfgr Received | 2019-11-06 |
| Device Manufacturer Date | 2018-08-24 |
| Date Added to Maude | 2019-11-15 |
| 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 | 3 |
| Brand Name | RING DRAINAGE CATHETER NEEDLE SET |
| Generic Name | GCB NEEDLE, CATHETER |
| Product Code | GCB |
| Date Received | 2019-11-15 |
| Model Number | N/A |
| Catalog Number | DLPN-40-25-RING |
| Lot Number | 9117559 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-11-15 |