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

Catalog Number 270400

Device Problems Defective Device (2588); No Apparent Adverse Event (3189)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Imdrf annex e code health effect: clinical code: (b)(4).Imdrf annex a code medical device problem code: (b)(4).

Event Description

It was reported that liquid did not come out.Per complaint details received: dear sir/madam, we have received a yellow card report concerning the above, the reporter informed us as follows: this initial report is being reported by lpch on behalf of the patient on (b)(6) 2021 the patient that a batch of a recent chloraprep liquid (insight) is not coming out.Batch number 0297542, expiry is 10/23.At the time of the report the outcome of the event was unknown.No medical history available.Other medications taken are unknown.No further information was provided.Please would you investigate the report and respond directly to the reporter, providing dmrc with a copy of the customer response and your investigation report.Please could you also let us know whether there have been any similar reports concerning this batch.

Manufacturer Narrative

No samples or photos were provided for evaluation.As a result, bd was unable to verify the reported issue or define a definitive root cause.The most probable root cause can be attributed to post manufacturing handling, which can provide enough force/impact to activate, crack and/or 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 handling.Without the actual sample a root cause can't be determined.The batch record for pn 270400 ln 0297542 was reviewed and there were no non-conformances related to broken ampoule during the manufacturing of this lot.No further action will be taken based on no adverse trend has been observed.Will continue to track & trend for this defect.

Event Description

It was reported that liquid did not come out.Per complaint details received: dear sir/madam, we have received a yellow card report concerning the above, please see attached pdf.We have opened file number mdr 032-07/21.The reporter informed us as follows: this initial report is being reported by lpch on behalf of the patient on (b)(6) 2021 the patient that a batch of a recent chloraprep liquid (insight) is not coming out.Batch number 0297542, expiry is 10/23.At the time of the report the outcome of the event was unknown.No medical history available.Other medications taken are unknown.No further information was provided.Please would you investigate the report and respond directly to the reporter, providing dmrc with a copy of the customer response and your investigation report.Please could you also let us know whether there have been any similar reports concerning this batch.

• Brand Name: CHLORAPREP ONE STEP
• 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: 12264603
• MDR Text Key: 265011331
• Report Number: 3004932373-2021-00352
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 270400
• Device Lot Number: 0297542
• Date Manufacturer Received: 08/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other