MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number SA-22854-EU

Device Problem Crack (1135)

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

Event Date 06/22/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that " the physician found that the needle hub was cracked.It was noticed when inserting the cvc.No blood was able to be drawn.Another pack was used for insertion.There was no reported patient harm.

Manufacturer Narrative

(b)(4).The customer report of a cracked needle hub was confirmed through visual inspection of the returned sample.The customer provided one photo of the introducer needle and returned one introducer needle for analysis.Definite signs of use were observed on the needle hub.Visual examination revealed the needle hub contained one lateral crack.Microscopic examination confirmed the crack in the introducer needle hub.The ifu provided with the kit informs the user, "read all package insert warnings, precautions and instructions prior to use.Failure to do so may result in severe patient injury or death".The ifu also states, "do not use if package is damaged".A device history record review was performed, and no relevant findings were identified.Based on these circumstances and the comments from r & d, the root cause of this complaint was design related.Teleflex has identified that the needle hub material was susceptible to cracking when placed under stress (i.E., pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.Capa has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.Corrective actions were not implemented at the time of this report.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that " the physician found that the needle hub was cracked.It was noticed when inserting the cvc.No blood was able to be drawn.Another pack was used for insertion.There was no reported patient harm.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17324271
• MDR Text Key: 319927739
• Report Number: 3006425876-2023-00672
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SA-22854-EU
• Device Lot Number: 71F23A1423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• 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: NOT REPORTED; NOT REPORTED