MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SLIC COMPONENT: 7 FR X 6"; ACCESSORIES, CATHETER

Catalog Number SS-14701

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "blood leaking from infusion extension set.On further examination, single lumen infusion catheter (slic) had visible crack.Slic was inserted into rt jugular introducer on march 5.No blood leaking until march 6.No interventions done to line prior to leaking, ie tightening, adding lines." no patient injury or consequence reported.The patient's condition is reported as fine.

Event Description

The complaint is reported as: "blood leaking from infusion extension set.On further examination, single lumen infusion catheter (slic) had visible crack.Slic was inserted into rt jugular introducer on march 5.No blood leaking until march 6.No interventions done to line prior to leaking, ie tightening, adding lines." no patient injury or consequence reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW SLIC COMPONENT: 7 FR X 6"
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11694825
• MDR Text Key: 246313349
• Report Number: 9680794-2021-00159
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• PMA/PMN Number: K781846
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SS-14701
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1