MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC KIT: 4 FR X 40 CM; CATHETER, PERCUTANEOUS

Catalog Number EU-24041-HPMSB

Device Problems Suction Problem (2170); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device (catalog# eu-24041-hpmsb) is not intended for sale in the us.Similar product/component sold in the us.

Event Description

The customer reports that the safety needle is faulty , and it is not possible to "draw up" using it.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The customer reports that the safety needle is faulty , and it is not possible to "draw up" using it.

• Brand Name: ARROW PICC KIT: 4 FR X 40 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9776396
• MDR Text Key: 181786007
• Report Number: 3006425876-2020-00217
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Catalogue Number: EU-24041-HPMSB
• Device Lot Number: 71F19L1182
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1