MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Catalog Number CDC-45552-VPS2

Device Problem Material Separation (1562)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The compliant is reported as: the hub broke off the picc when turning the patient.The catheter lumen slide clamp was engaged to prevent blood loss.The patient's condition is reported as fine.

Event Description

The compliant is reported as: the hub broke off the picc when turning the patient.The catheter lumen slide clamp was engaged to prevent blood loss.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The actual sample was not returned; however, the customer provided one photo for evaluation.The distal luer hub appeared to be detached from the distal lumen.The luer was not displayed in the photo.A full visual inspection could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with this kit warns the user , "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested." the customer report of a separated luer hub was confirmed by visual examination of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on sales history, 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.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Type of Device: CATHETER INTRAVSCULAR THERAPEU
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11088393
• MDR Text Key: 227352475
• Report Number: 1036844-2020-00332
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K153487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.