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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/11/2021

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

It was reported that cdc called and said that a piece of glass was in a package of chloraprep (scratched the patient).  verbatim: cdc called and said that a piece of glass was in a package of chloraprep (scratched the patient).(b)(4) is the info number, reference number is 930299, with a lot number of 1006468.They have pulled all the chloraprep with the lot numbers.

Event Description

It was reported that cdc called and said that a piece of glass was in a package of chloraprep (scratched the patient).  verbatim: cdc called and said that a piece of glass was in a package of chloraprep (scratched the patient).542977 is the infor number, reference number is 930299, with a lot number of 1006468.They have pulled all the chloraprep with the lot numbers.16-aug-2021 per email: thank you forwarding adverse event and complaint below.We have logged it under miq-08162021-1437.17-aug-2021 per email: thank you for your email, receipt confirmed.Please kindly note that assigned pv id number is (b)(4).

Manufacturer Narrative

No samples or photos were available for evaluation.As a result, bd was unable to verify the reported issue and determine a definitive root cause without an actual sample(s).The problem can be caused by a mix of factors such as a broken ampoule and a defective seal which can product loose glass in the package.According to the records, no adjustments were performed to the sealing equipment and no quality conformances were found.A production record review was completed for batch/lot 1006468 was reviewed and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot similar to the reported issue or that could have contributed to the reported failure mode.No further actions are required.This failure will continue to be tracked and trended.H3 other text : see narrative below.

Manufacturer Narrative

No samples or photos were available for evaluation.As a result, bd was unable to verify the reported issue and determine a definitive root cause without an actual sample(s).The problem can be caused by a mix of factors such as a broken ampoule and a defective seal which can product loose glass in the package.According to the records, no adjustments were performed to the sealing equipment and no quality conformances were found.A production record review was completed for batch/lot: 1006468 was reviewed and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot similar to the reported issue or that could have contributed to the reported failure mode.No further actions are required.This failure will continue to be tracked and trended.Patient identifiers were provided during a follow up response.Patient identifier added as additional information for this supplemental mdr h3 other text: see narrative below.

Event Description

Material no: 930299, batch no: 1006468.  it was reported that cdc called and said that a piece of glass was in a package of chloraprep (scratched the patient).  cdc called and said that a piece of glass was in a package of chloraprep (scratched the patient).(b)(4) is the infor number, reference number is (b)(4), with a lot number of 1006468.They have pulled all the chloraprep with the lot numbers.16-aug-2021 per email: thank you forwarding adverse event and complaint below.We have logged it under (b)(4).17-aug-2021 per email: thank you for your email, receipt confirmed.Please kindly note that assigned pv id number is (b)(4).

• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12363326
• MDR Text Key: 268081544
• Report Number: 3004932373-2021-00414
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 930299
• Device Lot Number: 1006468
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male