MAUDE Adverse Event Report: CARDINAL HEALTH (THAILAND) 222 LIMITED GLOVE SURGICAL PROTEXIS LATEX HYDROGEL; SURGEON'S GLOVES

Catalog Number 2D72LS75

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility for investigation.The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.The sample is enroute to the manufacturing facility.Once their investigation of it is completed, a follow up report will be filed.

Event Description

Cases were selective coronary angiograms (sca) with percutaneous coronary interventions (pci).During the pci the stickiness of the gloves would cause the coronary wire to dislodge from the lesion resulting in the physician needing to rewire the lesion.Per customer, no adverse effects to patients other than lengthened procedure times.No additional patient or event specifics provided by customer.

Manufacturer Narrative

The returned samples were from an unopened package.They were evaluated by donning testing, and were found to be a little tacky.Grip testing was found to be within range.The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.The manufacturing location had been moved, but the gloves continue to be manufactured using the same mold design and product dimensions, using the same test methods, and the same product specifications/quality standard.The chlorine concentration has been increased at the chlorination process to improve grip variation.We will continue to monitor complaints for any such issues.

• Brand Name: GLOVE SURGICAL PROTEXIS LATEX HYDROGEL
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• MDR Report Key: 8443702
• MDR Text Key: 139820741
• Report Number: 1423537-2019-00294
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380024054
• UDI-Public: 10885380024054
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2021
• Device Catalogue Number: 2D72LS75
• Device Lot Number: TS18100217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 02/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other