MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP HI LITE ORANGE; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 670815

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Material no.: 670815, batch no.:0354428.It was reported the product fell apart inside the packaging resulting in leakage.Addition to the below email, this is to bring to your notice that while inspecting the case cartons to trace dataloggers, one of the unit of cat# 670815 (batch# 0354428) found abnormal.This dispute unit was found in a case carton which has the pack size of 25 ea.Please find attached the photographs for your reference and request your advice to proceed further.Also we haven't yet received "(b)(6) specific" labels for these product and labeling is pending for a long time.1 unit in abnormal condition i.E.Solution oozed on the sponge.This unit was found in a sealed case carton which has the pack size of 25 ea."in (b)(6) nonconformance identified in chloraprep 26 ml, catalogue 670815.Leakage identified in sealed case carton.".

Manufacturer Narrative

The failure mode was confirmed based on photograph received for analysis showing orange stains on the original unopened package (lidding) and foam tip.Ampoules are made from onion tubing skin borosilicate type i glass, which are design to break when pressure is applied to activate applicator at a relatively low break force.When pressure is applied to the wings by a pinching force with the fingers, this activates the applicator, breaking the glass ampoule and releasing the chloraprep solution onto the foam tip.The most probable root cause can be attributed to post manufacturing handling, which can provide enough force/impact to activate and break the glass ampoule.Due to the nature of glass, it is possible to have an activated applicator and/or broken ampoule if the applicator undergoes excessive handing.The initial mdr was reported for "fell apart" however this complaint for found to be for pre-activation.Emdr follow up.Asroka 6/17/2021.

Event Description

Material no.: 670815.Batch no.:0354428.It was reported the product fell apart inside the packaging resulting in leakage.Addition to the below email, this is to bring to your notice that while inspecting the case cartons to trace dataloggers, one of the unit of cat# 670815 (batch# 0354428 ) found abnormal.This dispute unit was found in a case carton which has the pack size of 25 ea.Please find attached the photographs for your reference and request your advice to proceed further.Also we haven't yet received "india specific" labels for these product and labeling is pending for a long time.1.1 unit in abnormal condition i.E.Solution oozed on the sponge.This unit was found in a sealed case carton which has the pack size of 25 ea.Refer the attached photograph."in india nonconformance identified in chloraprep 26 ml, catalogue 670815.Leakage identified in sealed case carton.".

• Brand Name: CHLORAPREP ONE STEP HI LITE ORANGE
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• MDR Report Key: 11639700
• MDR Text Key: 266498742
• Report Number: 3004932373-2021-00184
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 670815
• Device Lot Number: 0354428
• Date Manufacturer Received: 05/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other