MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 9 FR; INTRODUCER, CATHETER

Model Number IPN033616

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Associated mdr# 9680794-2022-00670.

Event Description

It was reported that "when attaching the cannulas to the syringe, they are split at the attachments.When the patient was punctured, air aspiration occurred with the needle under the skin.This could also be simulated later in a cup of water.This happened with the same syringe with 2 different needles (1 from the set below, 1 from another cvc set).Air was drawn into the syringe instead of nacl." this report captures the issue detected during patient use.The patient's condition was not available.

Manufacturer Narrative

(b)(4).The customer returned one introducer needle and arrow raulerson syringe (ars) for analysis.Signs of use were observed inside the needle hub.Visual analysis of the returned needle revealed one large vertical crack in the needle hub.Multiple additional small cracks were also observed.It was confirmed that the hub on the returned sample is the new hub design, which matches the bill of materials.The needle length measured 2.875", which is within the specifications of 2.852"-2.93" per product drawing.The needle cannula outer diameter measured 0.0502" which is within the specifications of 0.0495"-0.0505" per the cannula product drawing.The needle cannula inner diameter measured 0.042", which is within the specifications of 0.041"-0.043" per the cannula product drawing.Functional testing was performed per the product ifu, which states "insert introducer needle with attached arrow raulerson syringe into vein and aspirate." the returned introducer needle was attached to the returned arrow raulerson syringe (ars).The returned needle was not able to draw or aspirate water due to the cracks in the needle hub.A device history record review was performed, and no relevant findings were identified.The customer report of a cracked needle hub was confirmed through visual inspection of the returned sample.Multiple vertical cracks were observed on the needle hub.The returned needle met all relevant dimensional requirements, and a device history record review was performed with no findings relevant to this investigation.Based on these circumstances and the comments from r & d, the root cause of this complaint is design related.Further investigation of this issue is being performed under a capa.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that " when attaching the cannulas to the syringe, they are split at the attachments.When the patient was punctured, air aspiration occurred with the needle under the skin.This could also be simulated later in a cup of water.This happened with the same syringe with 2 different needles (1 from the set below, 1 from another cvc set).Air was drawn into the syringe instead of nacl." this report captures the issue detected during patient use.The patient's condition was not available.*associated mdr#s 9680794-2022-00670.

• Brand Name: ARROW PSI SET: 9 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15684418
• MDR Text Key: 304917743
• Report Number: 9680794-2022-00671
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00080192101709
• UDI-Public: 0080192101709
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN033616
• Device Catalogue Number: SI-09903-E
• Device Lot Number: 14F21G0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CHLORHEXIDIN 2% DISINFECTANT WIPE.; CHLORHEXIDIN 2% DISINFECTANT WIPE.