MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number IPN031155

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the needle hub cracked.

Event Description

The customer reports that the needle hub cracked.

Manufacturer Narrative

(b)(4).The customer returned a product lidstock, one ars syringe, and two introducer needles.Visual examination revealed the first introducer needle contained three large cracks in the hub.The second introducer needle contained no defects or anomalies, so this was assumed to be a representative sample.The returned introducer needles were attached to the returned ars and flushed.The defective needle leaked a significant amount when flushed.The representative sample functioned as expected.A device history record review was performed with no relevant findings.The customer report of a cracked needle hub was confirmed by complaint investigation of the returned sample.One needle hub contained three large cracks, while the representative sample contained no defects.A device history record review was performed, and no relevant findings were identified.Based on the sample received, design caused or contributed to this event.A non-conformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9831047
• MDR Text Key: 183473075
• Report Number: 3006425876-2020-00228
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN031155
• Device Catalogue Number: DE-15854-S
• Device Lot Number: 71F19K1499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1