MAUDE Adverse Event Report: CARDINAL HEALTH LLC 200 GLOVE SURGICAL PROTEXIS PI CLASSIC; SURGEON'S GLOVES

Model Number	2D72PL70X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During placement of an implantable catheter for chemotherapy, it was reported that from the clinician¿s sterile nitrile gloves, the patient developed a sensation of generalized pruritus, generalized rash with appearance of hives, feeling of dyspnea, dizziness with tendency to worsen.Patient was sent to the emergency room for monitoring of condition and anaphylaxis.Patient required 02 therapy to raise saturation from 85-87% to 94%.40mg of defidramine iv and 100mg of hydrocortisone were administered to the patient.The patient was reported as stable after treatment.
Additional 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.
Additional Manufacturer Narrative
Supplemental report is being filed since the results of investigation are available.The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.The sample was not returned for evaluation but only wallet paper photo provided.Investigation found no change in material and process that may cause the reported incident in complaint lot.Reference to tsr#90077 test report that passed primary skin irritation (psi) testing per iso10993-10:2010 and the product also passed protein test both of astm d5712-15 and en455-3:2015.Pi classic gloves have passed a series of tests prescribed by regulatory agencies for the intended use.Therefore, the root cause could not determined for this case.We will continue to monitor trends for this product.

• Brand Name: GLOVE SURGICAL PROTEXIS PI CLASSIC
• Common Device Name: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH LLC 200; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15299257
• Report Number: 1423537-2022-00820
• Device Sequence Number: 12547536
• Product Code: KGO
• UDI-Device Identifier: 10885380031779
• UDI-Public: 10885380031779
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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 Model Number: 2D72PL70X
• Device Catalogue Number: 2D72PL70X
• Device Lot Number: TS21030199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Unknown
• Patient Weight: 92 KG