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

Catalog Number 930700NSB

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Inaccurate Information (4051)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that upon opening a new case of lot 0305485, product labeled ¿clear¿ and 30ea of product labeled ¿hi-lite orange¿ were found mixed in the case.

Event Description

It was reported that upon opening a new case of lot 0305485, product labeled ¿clear¿ and 30ea of product labeled ¿hi-lite orange¿ were found mixed in the case.

Manufacturer Narrative

One box of applicators and four photos were received by our quality team for evaluation.The master shipper boxes received are noted as box 94 and box 100.Photograph of box 100 was sent by the customer.The master shipper label for box 94 has the correct information for product code 930700nsb and lot: 0305485 confirming the chloraprep clear 10.5ml applicators.Inside box 94 are four 4 plastic bags with 3, 16, 10, 11 applicators respectively.All (40) applicators are 10.5ml clear applicator with a clear (no orange dye) pledget and correct greyed clear in-mold applicator body label.Applicators have the correct lot number and expiration date (l0305485 exp 07/23) printed on the body.The cavities of the applicator bodies range from cavity 9 to 23.All product on box 94 (40 applicators) is conforming from the information on the master shipper label to the applicator lot number, components, and clear in-mold label.The master shipper label for box 100 has the correct information for product code 930700nsb and lot: 0305485 confirming the chloraprep clear 10.5ml applicators.Inside box 100 are three (3) plastic bags with 31, 34, 36 applicators respectively.Two (2) bags for a total of seventy (70) applicators are 10.5ml clear applicator with a clear (no orange dye) pledget and correct greyed clear in-mold applicator body label.Applicators have the correct lot number and expiration date (l0305485 exp 07/23) printed on the body.The cavities of the applicator bodies range from cavity 9 to 23.From box 100, 2 bags with seventy (70) applicators have all conforming from the information on the master shipper label to the applicator lot number, components, and clear in-mold label.Inside box 100, 1 bag with 31 applicators have a clear (no orange dye) pledget and correct lot number and expiration date (l0305485 exp 07/23) printed on the applicator body; but have an incorrect orange (hi-lite orange) in-mold label.The cavities of the applicator bodies range from cavity 41 to 56.From box 100, 1 bag with thirty-one (31) non-conforming applicators with the manufacturing lot number 0305485 have the incorrect orange (hi-lite orange) in-mold label, instead of the correct greyed clear in-mold label; therefore, the incident can be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.A visual inspection of the retained samples (50) for product code/lot (930700nsb ¿ 0305485 exp 2023-07-31) was also performed and no nonconformance were found.All fifty (50) samples have a clear in-mold label on the applicator body and lot number (l0305485 exp 07/23) printed on the bodies.Based on the investigation, the most probable root cause of the mix bodies (hi-lite orange vs clear) was determined to be a mix of completed applicator bodes during pre-manufacturing or issuance of materials (human error).The only difference from the conforming vs nonconforming is the in-mold label between the hi-lite orange and clear is the word ¿clear¿ with the grey color background and the artwork number.All the other information in the in-mold label is identical, the name of the product (chloraprep one-step), size of the product (10.5ml applicator), active ingredients (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol), warning (flammable) and address is the same on both labels.The insert (instructions for use) for both products hi-lite orange and clear is the same.No product mix occurred during the packaging, warehouse storage, shipping, delivery, or by the customer due to each individual applicator has the lot number printed on the body.The applicator samples received for analysis from the customer both the clear (conforming) and orange (non-conforming) have the same lot number (l0305485 exp 07/23) printed on the bodies; therefore, this leads to the applicators (clear vs orange) may have mixed during pre-assembly of the lot in question.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: CHLORAPREP ONE-STEP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 11348440
• MDR Text Key: 232550289
• Report Number: 3004932373-2021-00059
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 930700NSB
• Device Lot Number: 0305485
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other