MAUDE Adverse Event Report: CORAM CVS SPECIALTY INFUSION SERVICES CENTRAL LINE KIT; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Catalog Number CORAM 11

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

Event Type  malfunction  

Event Description

My name is (b)(6).I am a patient.I'm reaching out with regards to the extremely poor quality control of the new dressing kits that i am receiving from (b)(6) pharmacy.Central line and port kits are supposed to have sterile gloves, not regular gloves, due to high risk of infection and patients going septic.I am appalled that the company has decreased its quality control and made such a tremendous oversight with this product.When i call for supplies they offer separate sterile gloves, but they do not have sizes in stock that fit my caregiver and nurse.This is unacceptable.I believe it should be audited.They have multiple complaints about the product and have done nothing to rectify the situation.Their actions could potentially lead to lethal consequences for patients with central lines, ports, etc.I'm not sure why these changes had been made in the first place to the kits, perhaps in a misguided attempt to save money.I would like to hear back from leadership about this matter asap.I can be reached at (b)(6) and (b)(6) sincerely, (b)(6).Fda safety report id # (b)(4).

• Brand Name: CENTRAL LINE KIT
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): CORAM CVS SPECIALTY INFUSION SERVICES
• MDR Report Key: 11581248
• MDR Text Key: 242991060
• Report Number: MW5100317
• Device Sequence Number: 1
• Product Code: PEZ
• UDI-Device Identifier: 10841767108311
• UDI-Public: (01)10841767108311
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/24/2021

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: 01/31/2022
• Device Catalogue Number: CORAM 11
• Device Lot Number: (10) 600000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 70