MAUDE Adverse Event Report: CIRPRO DE DELICIAS S.A. DE C.V. SMARTSLEEVE SURGICAL GOWN, 2XL LONG; GOWN, SURGICAL

Model Number	9071EL
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no sample or image available for this complaint.The report states there was a physical sample but later an email was received that indicated that the sample was discarded.The investigation was carried out with the information obtained from the customer report, lot number, and the batch record.According to the inspection record, no deviation was found in the manufacture of this particular lot.The device history record on the day of manufacturing for this particular product confirmed that the settings were within specifications.Without a physical sample or photograph illustrating the defect, it is not possible to determine the root cause of the defect in the product.The product is involved in different process of manufacturing and without any evidence of a photograph or a physical sample, it is difficult to determine the origin of the defect.Awareness documented training was provided to the employees involved in the process of this product in order to be alert about this kind of issue.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature in this catalog.
Event or Problem Description
Customer reported during procedure there was a tear in the surgical tech¿s gown.Sleeve tear was found during procedure.No treatment was required for the surgical tech.Additional antibiotics were administered to the patient prophylactically.The surgeon gave the patient keflex irrigation because of this incident due to possible contamination in addition to the cefazolin they received from anesthesia.

• Brand Name: SMARTSLEEVE SURGICAL GOWN, 2XL LONG
• Common Device Name: 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: 12342394
• Report Number: 1423537-2021-00664
• Device Sequence Number: 19967378
• Product Code: FYA
• UDI-Device Identifier: 10885380063428
• UDI-Public: 10885380063428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: 9071EL
• Device Catalogue Number: 9071EL
• Device Lot Number: 21CUD292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/19/2021
• Patient Sequence Number: 1