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

Catalog Number 930700

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Sharp Edges (4013)

Patient Problem Abrasion (1689)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Material# : 930700; batch#: 1305540.It was reported that there were sharps.We would like to file a serious quality compliant on item (b)(4) 10.5ml chlorapreps on lot number 1305540.We filed a psn on this incident.During a procedure yesterday, a patient complained about scratching on the area the chloraprep was applied.The area was bleeding and the end user found glass shards inside the packaging.I¿ve attached a picture.The stock of this lot has been set aside.

Manufacturer Narrative

A sample and photo was available for evaluation.Visual examination shows glass particle(s) inside the opened package which verified the reported issue.The foam tip was inspected and it is 100% welded onto the applicator body.The glass might have occurred during the assembly process which inserts a glass ampoule into the applicator body.The equipment has sensors to detect the ampoule presence and scrap non-conforming applicators.A glass ampoule may have been pre-activated during assembly and glass particle(s) may have landed on a nearby applicator.This occurrence is a rare anomaly and this is the first such occurrence on the auto 10.5 ml #2 assembly equipment during the past 12-month review.This failure will be categorized as an isolated event.A production record review was completed for batch/lot 1305540 and no non conformances were identified during the manufacturing of this lot.A training awareness was given to the manufacturing associates and the qa technicians to be aware of such an issue and to clean the equipment upon occurrences when identified.This was also communicated to all manufacturing associates, leads and supervisors.No further action is required.This failure will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported that there were sharps verbatim: we would like to file a serious quality compliant on item 170837a 10.5ml chlorapreps on lot number 1305540.We filed a psn on this incident.During a procedure yesterday, a patient complained about scratching on the area the chloraprep was applied.The area was bleeding and the end user found glass shards inside the packaging.I¿ve attached a picture.The stock of this lot has been set aside.17feb2022 kindly note that one follow up attempt was performed for this case, but no answer was received.If any new information was received, we will notify you.13mar2022:kindly note that one follow-up attempt was performed via phone (on 14-feb-2022 and 17-feb-2022) and e-mail (on 17-feb-2022) for the serious case (b)(4) (bd id: (b)(4)).On 17-feb-2022, reporter¿s reply was received in which the new reporter was mentioned and on 22-feb-2022, the completed fuq form was received (see correspondences attached) and the new case version was opened, i.E.(b)(4).

• 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
• 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: 13534890
• MDR Text Key: 289667278
• Report Number: 3004932373-2022-00049
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 930700
• Device Lot Number: 1305540
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female