MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MIDLINE CATHETERIZATION KIT

Model Number IPN036127

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Hematoma (1884); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the swg (spring wire guide) was stuck in the patient so the needle had to be entirely removed.Clinical consequences: it was impossible to insert the needle in the same vein, a hematoma appeared and loss of blood.A new device(s) was obtained for patient use.

Manufacturer Narrative

(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

It was reported that the swg (spring wire guide) was stuck in the patient so the needle had to be entirely removed.Clinical consequences: it was impossible to insert the needle in the same vein, a hematoma appeared and loss of blood.A new device(s) was obtained for patient use.

• Brand Name: MIDLINE CATHETERIZATION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9538453
• MDR Text Key: 178140969
• Report Number: 3006425876-2020-00017
• Device Sequence Number: 1
• Product Code: LJS
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/13/2021
• Device Model Number: IPN036127
• Device Catalogue Number: EU-02041-ML
• Device Lot Number: 71F19K2126
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1