MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 BD PURPREP; POVIDONE-IODINE 8.3% W/W (0.83% AVAILABLE IODINE)

Catalog Number 960120

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.

Event Description

Material no.: 960120, batch no.: 1166030.It was reported that one case had 5 devices that were damaged and leaking.Verbatim: southwest minnesota orthopedics and sports medicine customer received two cases of purprep.One of the cases had 5 devices that were damaged and leaking product.

• Brand Name: BD PURPREP
• Type of Device: POVIDONE-IODINE 8.3% W/W (0.83% AVAILABLE IODINE)
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12667863
• MDR Text Key: 277744877
• Report Number: 3004932373-2021-00474
• Device Sequence Number: 1
• Product Code: KXG
• 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: company representative,other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 960120
• Device Lot Number: 1166030
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other