MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS LLC MEDICHOICE POLYISOPRENE MICRO SURGICAL GLOVES; SURGEON'S GLOVES

Catalog Number 270-SPL

Device Problems Material Puncture/Hole (1504); Defective Device (2588); Material Integrity Problem (2978)

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

Event Date 10/03/2019

Event Type  malfunction  

Event Description

Our surgical departments switched to a new sterile glove earlier this year.We have had multiple reports where holes were found in the gloves right out of the package, easy tearing of the glove when being donned and the glove stretching out of shape after being worn for a period of time during a surgical case.Multiple lot numbers are involved.The manufacturer is aware and the sales representative have taken several packages of the defective gloves with them from our facility.All events occurred prior to procedures being started, no patient harm occurred.Manufacturer response for sterile surgical gloves, medichoice polyisoprene micro surgical gloves size 71/2 (per site reporter).Some of the defective gloves were taken by the sales representative.If no package was saved, the sales rep.States they are unable to follow-up on those.Manufacturer response for sterile surgical gloves, medichoice latex micro surgical gloves size 6 (per site reporter).Some of the defective gloves were taken by the sales representative.If no package was saved, the sales rep.States they are unable to follow-up on those.Manufacturer response for sterile surgical gloves, medichoice polyisoprene surgical gloves size 7 (per site reporter).Some of the defective gloves were taken by the sales representative.If no package was saved, the sales rep.States they are unable to follow-up on those.Manufacturer response for sterile surgical gloves, medichoice polyisoprene micro surgical gloves size 8 (per site reporter).Some of the defective gloves were taken by the sales representative.If no package was saved, the sales rep.States they are unable to follow-up on those.

• Brand Name: MEDICHOICE POLYISOPRENE MICRO SURGICAL GLOVES
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS LLC; 2301 robb drive; reno NV 89523
• MDR Report Key: 9161034
• MDR Text Key: 161385303
• Report Number: 9161034
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 270-SPL
• Device Lot Number: 1809054405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1