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

Catalog Number 931421

Device Problem Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 11/14/2020

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.: 931421; batch no.: 0118183.It was reported that a hair was found stuck to the side of the applicator.Per email: the hpra have received a report of a quality defect concerning the product chloraprep with tint 2% w/v / 70% v/v cutaneous solution, batch number 0118183, expiry 04/2023.This defect was described by the reporter as: hair found in a chloraprep stick 26ml stuck to side of applicator.Please see the attached image of the affected unit.The report was received from aileen barry, pharmacy department, sivuh, old blackrock road, cork.Please initiate a quality investigation regarding this defect.Please contact the reporter to organise collection of the unit.In the interim please provide this office with the following information to facilitate an assessment of this defect: total number of units in this batch.Number of units in this batch distributed to (b)(6).Other markets that this batch was distributed to, if any dates of first and last (if applicable, if batch fully distributed) distribution of this batch in ireland number of units remaining at primary wholesale in ireland have there been other similar complaints relating to this batch? if so please provide details & the defect rate have there been any other similar complaints relating to other batches of this product received in the last two years? if so, please provide the number of complaints received and defect rate please confirm the pa marketing authorisation number of the unit we look forward to receiving a response to the queries above.In the meantime, should you require any further information, or should further issues of this nature come to your attention, please do not hesitate in contacting me.

Manufacturer Narrative

A photo was provided for evaluation.Visual examination of the photo show a hair on the barrel of the applicator.As a result, bd verifies the foreign matter (hair) issue.The hair originates from an operator.The process has certain manual processes that may result in hair on the product.The procedures/process includes preventive measures for hair in product.It is possible for associates to accidentally shed hair onto product as they are loading components into their corresponding containers/packages, although associates wear hair nets, gloves, safety glasses, and head covers, if worn improperly it could lead to the reported issue.The most probable root cause is inadequate gowning by associate(s) and/or preventive measures during the manufacturing of the product.Production record review has been completed with batch/lot 0118183 and no non-conformances were noted during the manufacturing of this lot.No further actions are required at this time.This failure mode will continue to be tracked and trended.See narrative below.

Event Description

Material no.: 931421 batch no.: 0118183.It was reported that a hair was found stuck to the side of the applicator.01dec2020: reporter information has been updated.Edited customer information from eu bd affiliate communication.Per email: the hpra have received a report of a quality defect concerning the product chloraprep with tint 2% w/v / 70% v/v cutaneous solution, batch number 0118183, expiry 04/2023.This defect was described by the reporter as: hair found in a chloraprep stick 26ml stuck to side of applicator.Please see the attached image of the affected unit.The report was received from (b)(6).Please initiate a quality investigation regarding this defect.Please contact the reporter to organise collection of the unit.In the interim please provide this office with the following information to facilitate an assessment of this defect: 1.Total number of units in this batch; 2.Number of units in this batch distributed to ireland ; 3.Other markets that this batch was distributed to, if any; 4.Dates of first and last (if applicable, if batch fully distributed) distribution of this batch in ireland ; 5.Number of units remaining at primary wholesale in ireland ; 6.Have there been other similar complaints relating to this batch? if so please provide details & the defect rate; 7.Have there been any other similar complaints relating to other batches of this product received in the last two years? if so, please provide the number of complaints received and defect rate; 8.Please confirm the pa marketing authorisation number of the unit.We look forward to receiving a response to the queries above.In the meantime, should you require any further information, or should further issues of this nature come to your attention, please do not hesitate in contacting me.

• 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, INC; 5175 south royal atlanta dr; tucker GA 30084
• MDR Report Key: 11004085
• MDR Text Key: 221545910
• Report Number: 3004932373-2020-00149
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 931421
• Device Lot Number: 0118183
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 01/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other