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

Model Number 2D7255I

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

At the time of this investigation no sample or lot number was provided.Without the lot number and sample, we were not able to review the device history record (dhr) and we were not able to evaluate the issue sample.We were unable to determine the root cause for the reported event.If a sample is provided at a later date a follow-up will be provided.At this time no corrective action will be taken.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.

Event Description

Based on information received from the customer, a chest tube was inserted on (b)(6) 2019 and then replaced on (b)(6) 2019 when the patient later had surgery a fingertip of the glove was reportedly found in the chest cavity.The physician was unaware it had pulled off.

• Brand Name: GLOVE SURGICAL TRIFEX
• 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
• 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: 8636590
• MDR Text Key: 146058325
• Report Number: 1423537-2019-00318
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2D7255I
• Device Catalogue Number: 2D7255I
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other