MAUDE Adverse Event Report: COVIDIEN 1920 POP'N COUNT; NEEDLE, SUTURING, DISPOSABLE

Model Number 31142386

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports that needle has spliced through the needle counter.The incident has led to a contaminated sharps injury.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.Physical samples were not received for the investigation however three photos were provided.The photos were visually evaluated, and the reported issue was confirmed.The photos appears to show a needle going through the needle counter.The potential root cause for the perforation generated in the needle counter is user misuse as the height of the needle appears to exceed the height of the needle counter.A production notification was sent to all personnel to ensure that they are aware of the condition reported.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will continue to monitor the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 1920 POP'N COUNT
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9416764
• MDR Text Key: 169254256
• Report Number: 9612030-2019-02370
• Device Sequence Number: 1
• Product Code: GAB
• UDI-Device Identifier: 30884527016420
• UDI-Public: 30884527016420
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31142386
• Device Catalogue Number: 31142386
• Date Manufacturer Received: 11/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other