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

Catalog Number CHLORAPREP UNKNOWN

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported no fluid coming from applicator.

Manufacturer Narrative

No samples or photos were received for evaluation.Although the tracking information provided stated the shipment was delivered, site quality engineers confirmed it was not available for the investigation analysis.Two previous complaints from the same product code and lot (9149555) related to complaint code "solution not enough" have been received from sep2018 to sep2020.No adverse trend observed, defect is within control limits.Production batch records for applicator were reviewed for the lot number 9149555 and no non-conformances were noted during the manufacturing of this lot.Records indicate that the reviewed batch record passed all the in-process inspections.In addition to this, batch record from ampoule utilized on applicator was reviewed.Ampoule lot assigned to applicator was 9122550.As part of the verifications done to the solution filling machine, filled ampoules are being weighed in order to assure solution is according to specification of 1.5ml.No issues were noted during this verification ampoule weight lower specification was 2.265g and upper specification was 2.530 g.No statistical difference was observed from start up ampoule weight vs 1st inspection ampoule weight.Statistical difference was found from ¿start up ampoule weight¿ vs ¿2nd inspection ampoule weight¿ and between ¿1st inspection ampoule weight¿ vs ¿2nd inspection ampoule weight¿.Statistical difference was due to the ampoule weight was greater on 2nd inspection (ave 2.4305 g) compared to start up (ave 2.3756 g) and 1st inspection (ave 2.3782 g).As a result, the failure mode cannot be verified and a root cause cannot be determined.No further actions are required at this time.This failure mode will continue to be tracked and trended.

Event Description

It was reported no fluid coming from applicator.

Manufacturer Narrative

A sample was returned for evaluation for this record.One (1) sample was provided by the customer to perform investigation, package was received torn and with a black stain.Even though the package was received with some damage, the applicator inside was received with no visual damage.The applicator ampoule was analyzed and it was observed that glass was broken, which is an indication that is was activated.Glass was observed to be adhered/stuck in between them.This normally happens due to the presence of solution.In addition to this, dry drops were observed on the broken glass walls which is also an indication of solution presence.Based on these findings, it can be concluded the applicator had solution but unfortunately the amount of solution cannot be determined after activation.Unfortunately, bd is unable to verify the failure mode that there was no solution on the applicator.The root cause cannot be defined at this time.No further actions are required at this time.This failure mode will continue to be tracked and trended.

Event Description

It was reported no fluid coming from applicator.

• Brand Name: CHLORAPREP UNKNOWN
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10687494
• MDR Text Key: 212334345
• Report Number: 3004932373-2020-00075
• Device Sequence Number: 1
• Product Code: KXG
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2021

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: CHLORAPREP UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 09/23/2020; 09/23/2020
• Supplement Dates FDA Received: 12/03/2020; 01/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other