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

Model Number 2D72PL70X

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

Patient Problem Anaphylactic Shock (1703)

Event Date 07/13/2022

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 298659151
• Report Number: 1423537-2022-00820
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380031779
• UDI-Public: 10885380031779
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 92 KG