MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW DOUBLE LUMEN CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Skin Discoloration (2074)

Event Date 01/13/2018

Event Type  Injury  

Event Description

Central line was leaking fluid.The ij insertion site was hard and discolored.Patient's blood pressure was labile with turns.The line was removed.The nurse observed that the line was not the same length as other arrow ijs that she has seen.

• Brand Name: ARROW DOUBLE LUMEN CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 11245 n. distribution cove; olive branch MS 38654
• MDR Report Key: 7747266
• MDR Text Key: 115951874
• Report Number: 7747266
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018,01/30/2018

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
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 22995 DA
• Patient Weight: 152