MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-02 for N/A UNKNOWN manufactured by Cook Inc.
[182925038]
Date of event: (b)(6) 2020. Suspect medical device: 14f mac-loc pigtail catheter. Occupation: patient safety specialist. Pma/510(k) #: unknown. 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
[182925039]
It was reported an unknown patient required the placement of a "14f locking loop pigtail catheter" in the 8th intercostal space on the right posterior axillary for pleural drainage. The operator reported "the patients chest tube hub snapped off from the pigtail itself, revealing the wires and disconnecting the patient from suction. " the chest tube was subsequently removed from the patient and an x-ray confirmed full removal. No other adverse effects were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00517 |
| MDR Report Key | 9774259 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| Generic Name | GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY |
| Product Code | GBO |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-03-16 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2020-03-02 |