MAUDE Adverse Event Report: A PLUS INTERNATIONAL A PLUS INTERNATIONAL; LAP SPONGE

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104); Material Disintegration (1177)

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

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

Resource optimization and innovation, llc is a registered convenience kit manufacturer.The component, a bulk non-sterile finished medical device (lap sponge) is used in the kit as received from the component manufacturer (a-plus international, (b)(4)).The kit is assembled, sterilized and supplied sterile as single-use kits for patient use.The component was a lap sponge 18x18 pre-washed look banded 5, catalog no.Ls-1818-fs, lot no.405921, 510(k) no.881395.The blue cord broke off of the lap sponge and the rubber band aournd lap sponges disintegrated.This was identified while using the sponges on a patient.

Event Description

Blue cord broke off of lap sponge and rubber band around the lap sponges was disintegrating.This was identified while using the sponges on a patient.

• Brand Name: A PLUS INTERNATIONAL
• Type of Device: LAP SPONGE
• Manufacturer (Section D): A PLUS INTERNATIONAL; chino CA
• Manufacturer (Section G): RESOURCE OPTIMIZATION AND INNOVATION, LLC; 2909 n. neergrad; springfield MO 65803
• Manufacturer Contact: debra seilling-ferguson ; 2909 n. neergard; springfield, MO 65803 ; 4168209037
• MDR Report Key: 7328613
• MDR Text Key: 102224739
• Report Number: 3004513970-2018-00001
• Device Sequence Number: 1
• Product Code: EFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: LS-1818-PS
• Device Lot Number: 405921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1