MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC KIT; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number VASCULAR UNKNOWN

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Mdr report key (b)(4), mdr text key (b)(4).

Event Description

According to the maude report: "patient arm was bleeding.The peripherally inserted central catheter was removed and appeared to be damaged".

Manufacturer Narrative

(b)(4).Mdr report key (b)(4)/mdr text key (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.

Event Description

According to the maude report: "patient arm was bleeding.The peripherally inserted central catheter was removed and appeared to be damaged".

• Brand Name: ARROW PICC KIT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10659950
• MDR Text Key: 212771177
• Report Number: 9680794-2020-00406
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

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: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/10/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.