MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-03-07 for APPARATUS, SUCTION, PATIENT CARE 50-7050 manufactured by Carefusion, Inc.
[138085035]
(b)(4): initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4). No sample was returned for analysis. Visual analysis of the customer provided photograph confirmed the reported failure mode (broken). The catheter was? Broken? Proximal to the cuff ring on the catheter. An evaluation of the provided photograph was not able to determine the cause of the observed defect. A device history record review could not be completed as no batch number was provided. Since no complaint sample was provided for evaluation and a device history record review was unable to be performed, the investigation was not able to identify a probable root cause to the reported failure mode. Since no probable root cause was identified, the investigation was not able to identify any corrective or preventive actions. This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.
Patient Sequence No: 1, Text Type: N, H10
[138085036]
It was reported that the polyester cuff was outside. During the training it is noticed that the catheter is damaged. The patient was taken to the clinic and the catheter was removed. It is unknown how the error occurred. Self-inflicted cause can neither be confirmed nor excluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2019-00016 |
| MDR Report Key | 8398712 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-03-04 |
| Date Added to Maude | 2019-03-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPARATUS, SUCTION, PATIENT CARE |
| Generic Name | PLEURX PLEURAL CATHETER MINI KIT |
| Product Code | DWM |
| Date Received | 2019-03-07 |
| Catalog Number | 50-7050 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 400 EAST FOSTER RD MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-07 |