MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 12 FR X 20 CM ANTI; CATHETER HEMODIALYSIS NON IMPL

Catalog Number CDA-25122-U1A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: a patient needed a dialysis line to be placed in the internal jugular vein.The doctor gathered the needed 16 cm dialysis line needed for internal jugular vein placement.During line placement under u/s guidance, was noticed that the line looked too long, x-ray confirmed that indeed the catheter was 20 cms.The packaging was reexamined and was noted to have two labels, the first stating that there was a 16cms line, while the second stated that there was a 20 cms line within the contents.X-ray confirmed that the line was in the right atrium of the heart.Line d/c'd and a new 16 cm line was placed.No adverse harm to patient.Vital signs stable throughout.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The customer reports: a patient needed a dialysis line to be placed in the internal jugular vein.The doctor gathered the needed 16 cm dialysis line needed for internal jugular vein placement.During line placement under u/s guidance, was noticed that the line looked too long, x-ray confirmed that indeed the catheter was 20 cms.The packaging was reexamined and was noted to have two labels, the first stating that there was a 16cms line, while the second stated that there was a 20 cms line within the contents.X-ray confirmed that the line was in the right atrium of the heart.Line d/c'd and a new 16 cm line was placed.No adverse harm to patient.Vital signs stable throughout.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 12 FR X 20 CM ANTI
• Type of Device: CATHETER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8902608
• MDR Text Key: 156937857
• Report Number: 9680794-2019-00322
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• 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: 08/08/2019

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: Health Professional
• Device Catalogue Number: CDA-25122-U1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention