MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TOWEL,OR,DSP,ST,BLUE,DLX,10/PK,8PK/CS

Catalog Number	MDT2168210
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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).

• Common Device Name: TOWEL,OR,DSP,ST,BLUE,DLX,10/PK,8PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7562341
• Report Number: 1417592-2018-00036
• Device Sequence Number: 13833851
• Product Code: FRL
• UDI-Device Identifier: 20080196743442
• UDI-Public: 20080196743442
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: MDT2168210
• Device Lot Number: 84318010065
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR