MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. DURA-CUF; BLOOD PRESSURE CUFF

Lot Number	040241165
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Caustic/Chemical Burns (2549); Contact Dermatitis (4546)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226 a1, a4-6: not provided by the customer h4: not available at this time gehc's investigation is on-going at this time.A follow-up report will be submitted when the investigation is completed.
Event or Problem Description
It was reported that a patient sustained a skin reaction to the soft-cuf nibp cuff requiring treatment.
Additional Manufacturer Narrative
The customer reported that a patient sustained a skin reaction to the ge healthcare (gehc) noninvasive blood pressure cuff requiring treatment.It is not known what treatment was provided.While it was initially thought that the soft-cuf was at issue, gehc subsequently learned that the dura-cuf was actually in use with the patient at the time of the event.Gehc investigated by visiting the customer site to interview staff and observe their practices, testing similar cuffs, and performing historical data review.The investigation concluded the root cause was the use of an unapproved cleaning agent and failure to follow the instructions for use with respect to proper cleaning and disinfection.Additional education has been provided to the customer staff.

• Brand Name: DURA-CUF
• Common Device Name: BLOOD PRESSURE CUFF
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: kristof soos ; 8200 w tower ave; milwaukee, WI 53223
• MDR Report Key: 19191973
• Report Number: 3008729547-2024-00003
• Device Sequence Number: 18056964
• Product Code: DXQ
• UDI-Device Identifier: 00840682107099
• UDI-Public: 00840682107099
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: 040241165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female