MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-01 for MDT2168210 manufactured by Medline Industries Inc..
[110195417]
It was reported that in the middle of the dialysis catheter insertion, the loose string from the or towel prevented the dialysis catheter to advance into right neck (jugular vein). Per report, the loose string wrapped and tangled around the dialysis catheter that was being inserted. Reportedly, at the start of the procedure, ten packs of sterile towels were opened onto the sterile tray and these towels were used to prep and drape the incisional area (right neck). The loose string was reportedly successfully removed from tangling around the dialysis catheter and the dialysis catheter was placed without further issues. Per report, the patient was not under sedation and only local anesthesia was administered for this procedure. There was no serious injury reported related to this event. Due to the reported incident and in an abundance of caution, this medwatch is being filed. The sample is not available to be returned for evaluation. A root cause cannot be determined at this time. No additional information is available. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[110195418]
It was reported that in the middle of the dialysis catheter insertion, the loose string from the or towel prevented the dialysis catheter to advance into right neck (jugular vein).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00036 |
| MDR Report Key | 7562341 |
| Date Received | 2018-06-01 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-06-01 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | TOWEL,OR,DSP,ST,BLUE,DLX,10/PK,8PK/CS |
| Product Code | FRL |
| Date Received | 2018-06-01 |
| Catalog Number | MDT2168210 |
| Lot Number | 84318010065 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2018-06-01 |