MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 5-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-25855

Device Problem Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 10/22/2020

Event Type  Death  

Manufacturer Narrative

Qn#(b)(4).The customer provided two photos for evaluation.The first photo displayed two dilators.One dilator has a separated tip towards the distal end of the dilator body.The separated tip portion appears to be present in the image.The second photo displayed a product lidstock.The customer report of a separated dilator tip was confirmed by complaint investigation of the customer supplied photo.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: the tip of the dilator snapped off while being removed from the skin having already been used to dilate down to the vein.Icu consultant unable to retrieve plastic section and trauma surgeon called in for consult.It was reported "2mm of the tip was unable to be retrieved despite attendance by trauma surgeon who has closed the wound.Piece definitely not intravascular, but in the soft tissue of the neck.".

Event Description

The complaint is reported as: the tip of the dilator snapped off while being removed from the skin having already been used to dilate down to the vein.Icu consultant unable to retrieve plastic section and trauma surgeon called in for consult.It was reported "2mm of the tip was unable to be retrieved despite attendance by trauma surgeon who has closed the wound.Piece definitely not intravascular, but in the soft tissue of the neck''.

Manufacturer Narrative

(b)(4).Additional information received indicates "the patient has since passed away unrelated to this incident." the cause of death unknown.The patient reported to be palliated due to comorbidities and poor outcome on (b)(6) 2020, and on (b)(6) 2020, the patient died.Corrected data: section h.1 : correction to 'death'.

• Brand Name: ARROW CVC SET: 5-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10835600
• MDR Text Key: 216097938
• Report Number: 3006425876-2020-00971
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Catalogue Number: CS-25855
• Device Lot Number: 71F20E0449
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Death; Required Intervention