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

Catalog Number 930299

Device Problem Defective Device (2588)

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

Event Date 04/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pr (b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.

Event Description

Material no.: 930299, batch no.: 0324920.It was reported by the health professional that the applicator does not have enough liquid or was underfilled to accomplish proper cleaning of the site.Description: the ed tech reported while getting blood cultures the prep did not have enough liquid or was underfilled to accomplish proper cleaning of the site to avoid contaminated samples.Multiple preps were needed (4).This is in response to backorders with the original 3ml product recall/backorder.Site has had to use 10 ml sub #930700 to accomplish a long enough dry time for effective blood culture collection/draws.

Manufacturer Narrative

The batch record for pn 930299 ln 0324920 was reviewed and there were no non-conformances related to broken ampoule during the manufacturing of this lot.Based on no photograph or sample was received for analysis from the customer, the failure mode could not be confirmed.The ampoule is made of glass and is designed to break 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.Follow up emdr (b)(4).H3 other text: see narrative.

Event Description

Material no.: 930299.Batch no.: 0324920.It was reported by the health professional that the applicator does not have enough liquid or was underfilled to accomplish proper cleaning of the site.Description: the ed tech reported while getting blood cultures the prep did not have enough liquid or was underfilled to accomplish proper cleaning of the site to avoid contaminated samples.Multiple preps were needed (4).This is in response to backorders with the original 3ml product recall/backorder.Site has had to use 10 ml sub #930700 to accomplish a long enough dry time for effective blood culture collection/draws.

• Brand Name: CHLORAPREP ONE STEP FREPP
• 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: 11884470
• MDR Text Key: 263487377
• Report Number: 3004932373-2021-00257
• Device Sequence Number: 1
• Product Code: KXF
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 930299
• Device Lot Number: 0324920
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 08/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other