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

Catalog Number 930500NSB

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  Injury  

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 by the distributor that 2 chloraprep applicators had glass embedded in the foam found during inspection.Good morning bd team, please see attached notification (b)(4) for discovery of 2 each item 930500nsb with glass shard embedded in applicator foam.Lot 0316970 was delivered 12/08/20 on po 149959 line 50.After the discovery of 2 each, our qa team performed finished goods sampling for additional glass shards in product, no additional nonconformances were found.There is no additional remaining raw stock of lot 0316970 in the mai warehouse and no product is hold.The 2 each samples have been retained and can be sent per your request.Please let me know if you would like the samples returned to your attention.I would be glad to address any questions as best i can.Thank you in advance for your time and best regards,.

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: e2403.Imdrf annex a code medical device problem code: a25.Photos and samples were available for evaluation.A vision system was used to examine the samples and indeed there is glass embedded on the foam on both applicators returned.Bd was able to verify a sponge/foam issue occurred.Because this was identified during inspection, no reported harm was done to the patient or admin.An investigation was performed at the machine and the glass may have come from a broken ampoule during the assembly process of the product.A manufacturing instruction advises associates to clean any residue (possibly from broken ampoules) on the pre-feeder conveyor with a damp cloth.It is possible that this was not followed and broken ampoule residue made it to the welding nests in the assembly process.As the foam was welded onto the plastic applicator, the piece of glass became embedded onto the foam.A device history record review was completed for batch/lot 0316970 and there are no defects reported related to "glass on foam or plastic body" during routine in-process inspections during the packaging of the lot.An awareness training has been provided to the associated to reinforce this instruction.No further actions are required at this time.This failure will continue to be tracked and trended.H3 other text: see narrative below.

Event Description

It was reported by the distributor that 2 chloraprep applicators had glass embedded in the foam found during inspection.Good morning bd team, please see attached notification 200035288 for discovery of 2 each item 930500nsb with glass shard embedded in applicator foam.Lot 0316970 was delivered 12/08/20 on po 149959 line 50.After the discovery of 2 each, our qa team performed finished goods sampling for additional glass shards in product, no additional nonconformances were found.There is no additional remaining raw stock of lot 0316970 in the mai warehouse and no product is hold.The 2 each samples have been retained and can be sent per your request.Please let me know if you would like the samples returned to your attention.I would be glad to address any questions as best i can.Thank you in advance for your time and best regards.

• 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: 11918048
• MDR Text Key: 265978848
• Report Number: 3004932373-2021-00269
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 930500NSB
• Device Lot Number: 0316970
• Date Manufacturer Received: 08/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other