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

Model Number	31142386
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Customer reports that needle has spliced through the needle counter.The incident has led to a contaminated sharps injury.
Additional 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
• Common Device Name: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9416764
• Report Number: 9612030-2019-02370
• Device Sequence Number: 2579626
• Product Code: GAB
• UDI-Device Identifier: 30884527016420
• UDI-Public: 30884527016420
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 31142386
• Device Catalogue Number: 31142386
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other