MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for MEDLINE MDT2168210 manufactured by Medline Industries, Inc..
[107483848]
Patient Sequence No: 1, Text Type: N, H10
[107483849]
Patient was prepped and draped to have a dialysis catheter installed on right upper neck. Sterile towels were draped around incisional area. While doctor was trying to advance dialysis catheter over wire he encountered difficulty and the catheter was unable to make a smooth transition. It was noted there was a string wrapped around the catheter preventing the catheter to be advanced. String was a lose thread from the sterile towel. The thread had to be removed from around the catheter and before the catheter could be installed and placed successfully. Manufacturer response for sterile disposable towel, sterile disposable towel (per site reporter). They are to make their investigation a priority.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7489978 |
| MDR Report Key | 7489978 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-04-30 |
| Report Date | 2018-05-04 |
| Date Reported to FDA | 2018-05-04 |
| Date Reported to Mfgr | 2018-05-04 |
| Date Added to Maude | 2018-05-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2018-05-07 |
| Model Number | MDT2168210 |
| Catalog Number | MDT2168210 |
| Lot Number | 84318010065 |
| ID Number | STERILE DISPOSABLE TOWEL |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1204 TOWNLINE RD ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-07 |