MAUDE Adverse Event Report: TELEFLEX MEDICAL PILLING; GAUZE/SPONGE, INTERNAL

Model Number IPN004223

Device Problem Packaging Problem (3007)

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

Event Date 06/14/2018

Event Type  malfunction  

Event Description

Package was opened for spine procedure.Upon counting, package had 11 sponges instead of the usual 10.Pack was removed from sterile field and isolated per policy.

• Brand Name: PILLING
• Type of Device: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 7792936
• MDR Text Key: 117466641
• Report Number: 7792936
• Device Sequence Number: 1
• Product Code: EFQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN004223
• Device Catalogue Number: 200100
• Device Lot Number: 17E1758
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other