MAUDE Adverse Event Report: CAREFUSION, INC BD E-Z SCRUB; CHLORAHEXIDINE GLUCONATE SOLUTION

Catalog Number 371073

Device Problem Unsealed Device Packaging (1444)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

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

In the brush box with reference 371073, two damaged parts came out.We realized the damage when we were labeling the material one is broken, the other is manufacturing damaged.Inf.Additional: the customer reports that manufacturing damage means that the package is broken.

Manufacturer Narrative

Photos are available for evaluation.Visual examination of the photo shows a break in the package seal.As a result, bd was able to verify the reported issue.Based on the photos, it is likely a nail pick was misplaced and was in the seal path, causing an inadequate seal.From the production record batch review of batch/lot 0147549 and retain review, it is unclear how the the breached seal occurred and shows no findings, deviations, or discrepancies that would attribute to this issue.All challenges for vision system and ipqc for seal integrity passed per batch record and inspection of retains did not show this defect.No further actions are required at this time.This failure mode will continue to be tracked and trended.

Event Description

In the brush box with reference (b)(4), two damaged parts came out.We realized the damage when we were labeling the material.1 one is broken.2.The other is manufacturing damaged.** add.Inf.: the customer reports that manufacturing damage means that the package is broken.*** ** add.Inf: dec8, 2020: the customer respond ¿the product was activated, before using it already came activated in the original box¿.

• Brand Name: BD E-Z SCRUB
• Type of Device: CHLORAHEXIDINE GLUCONATE SOLUTION
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 11108243
• MDR Text Key: 227062046
• Report Number: 1710034-2020-00834
• Device Sequence Number: 1
• Product Code: LRJ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 371073
• Device Lot Number: 0147549
• Date Manufacturer Received: 04/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other