MAUDE Adverse Event Report: CIRPRO DE DELICIAS S.A. DE C.V. SMARTGOWN, X-LARGE/X-LONG, RAGLAN; GOWN, SURGICAL

Catalog Number 39049

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

The lot number was provided, therefore the device history record was able to be reviewed.The product was inspected and no quality issues were detected.Historical trending was done.A sample was not available for evaluation, however three images were provided.Strikethrough could not be confirmed based on the visual evaluation of the images provided.The images do show saturation of fluid at the cuff due to channeling.Images show the right glove was not extended to cover the sleeve beyond the seam of the cuff.A photo showing the fit and placement of the left glove was not provided.Saturation was present on the left sleeve and cuff.Saturation on the left sleeve channeled onto the cuff, and saturation at the cuff permits channeling into the interior of the sleeve.All finished goods are made from qualified material that is tested before use.Final finished product must meet product specification and process requirements before final release to salable inventory.Based on the evaluation of the information and images provided, the issue of strikethrough could not be confirmed and the root cause was unable to be determined.No corrective action was taken, however we will continue to monitor for complaints of this nature.

Event Description

While doing an appendectomy, a male resident had fluid go through, and his arm and hand were stained with blood.The resident had an hiv test done, and it was negative.The resident left the hospital, so there is no additional information about him (no age, weight etc).

Manufacturer Narrative

This follow up report is being filed based on sample receipt.Two representative samples (in sealed packaging - unopened) were received by the manufacturing facility.Evaluation of the representative samples was conducted by the manufacturing facility and no issues were found.Raw material was reported as acceptable.Based on this information, the report of strike through cannot be confirmed.We will continue to monitor complaints for such issues.

• Brand Name: SMARTGOWN, X-LARGE/X-LONG, RAGLAN
• 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
• MDR Report Key: 7670821
• MDR Text Key: 113469797
• Report Number: 1423537-2018-00221
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380108693
• UDI-Public: 10885380108693
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 39049
• Device Lot Number: 18CUD136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Date Manufacturer Received: 06/14/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other