MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for UNK manufactured by Medline Industries Inc..
[81136785]
The account reported the tip of a suction catheter was discovered to be missing during a c-section. Account stated there did not appear to be any fracture lines on the catheter, but could not rule out the tip breaking and falling into the surgical site. The surgical site was surgically explored and the tip was not found. The patient was monitored and no adverse medical problems occurred. The account listed both cardinal health and medline as the manufacturers. Multiple attempts were made to obtain a product number was not provided for the c-section pack or for the suction catheter device. The suction catheter was returned and the root cause cannot be determined. However, it cannot be ruled out that the tip was broken prior to use or user error as a factor. Due to the reported incident and in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[81136786]
It was reported that the tip of a suction catheter may have broken and fallen into a surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00020 |
| MDR Report Key | 6742361 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-06-26 |
| Date Added to Maude | 2017-07-25 |
| 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 | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | SUCTION CATHETER IN C-SECTION PACK |
| Product Code | OHM |
| Date Received | 2017-07-25 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-25 |