MAUDE Adverse Event Report: CIRPRO DE DELICIAS S.A. DE C.V. AAMI 4 BREATHABLE RAG BNS XL; GOWN, SURGICAL

Model Number 39045NA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

Nurse reported blood exposure with a cardinal health gown from one of their custom packs in the obstetrics (ob) department.The exposure reportedly occurred during a cesarean birth procedure lasting approximately one hour, but without delay in the procedure.The (b)(6) female nurse had lab work completed following the exposure.

• Brand Name: AAMI 4 BREATHABLE RAG BNS XL
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CIRPRO DE DELICIAS S.A. DE C.V.; las virgenes industrial park,; delicias, chihuahua 33019 ; MX 33019
• Manufacturer (Section G): CIRPRO DE DELICIAS S.A. DE C.V.; las virgenes industrial park,; delicias, chihuahua 33019 ; MX 33019
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 9461577
• MDR Text Key: 206827870
• Report Number: 1423537-2019-00379
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380134425
• UDI-Public: 10885380134425
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39045NA
• Device Catalogue Number: 39045NA
• Device Lot Number: 0679DD2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 60