MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARROW(R) VPS(R) ACCESS KIT; CATHETER, ULTRASOUND, INTRAVAS

Catalog Number ASK-04001-UNHS

Device Problem Material Separation (1562)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: lidocaine needle separated when they deployed the safety mechanism.There was no patient or clinician injury.The patient's condition is reported as fine.

Event Description

The complaint is reported as: lidocaine needle separated when they deployed the safety mechanism.There was no patient or clinician injury.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4) the customer returned one injection needle for evaluation.Visual examination revealed the needle cannula was separated from the hub.The needle cannula was able to fit in the hub; however, it was loose and easily removed.R & d and manufacturing were consulted.They indicated that based on the damage observed, the likely root cause of this complaint is supplier related.The ifus provided with this kit state the following: "do not use if package has been previously opened or damaged." "inspect package, kit components and stylet carefully before use.Do not use if packaging or components are damaged." the reported complaint that the needle cannula separated from its hub was confirmed.Visual examination revealed the needle cannula was separated from the hub.The likely root cause of this complaint is supplier related.A nonconformance request has been initiated to further investigate this issue.

• Brand Name: ARROW ARROW(R) VPS(R) ACCESS KIT
• Type of Device: CATHETER, ULTRASOUND, INTRAVAS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12262402
• MDR Text Key: 266582746
• Report Number: 1036844-2021-00147
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• PMA/PMN Number: K103255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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: Health Professional
• Device Catalogue Number: ASK-04001-UNHS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1