MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI SET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number SI-11142

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer initially reports that the md found the needle defective.Additional information indicates that the user tried to connect the syringe and the needle, but the needle was too loose to connect.

Event Description

The customer initially reports that the md found the needle defective.Additional information indicates that the user tried to connect the syringe and the needle, but the needle was too loose to connect.

Manufacturer Narrative

Qn#(b)(4).The customer returned an introducer needle for evaluation.The needle contained obvious signs of use in the form of biological material.Visual and microscopic examination of the needle revealed a single crack and several scratches in the introducer needle hub.The returned needle was attached to a lab inventory syringe and water was aspirated and purged.A significant amount of water and air leakage was detected from the needle hub.A device history record review was performed with no relevant findings identified.The reported complaint that the introducer needle hub was cracked was confirmed by complaint investigation.The returned introducer needle hub contained a single crack and several scratches inside the hub.A device history record review was performed and no relevant manufacturing issues were identified.Further investigation of this issue is being conducted under a capa.The capa failure investigation indicates that the probable cause is design related.

• Brand Name: ARROW MULTI-LUMEN/PSI SET
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9817558
• MDR Text Key: 182935840
• Report Number: 3006425876-2020-00255
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K002507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: SI-11142
• Device Lot Number: 71F18C0280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1