MAUDE Adverse Event Report: ADVANCED MEDICAL SOLUTIONS LTD LIQUIBAND OCTYL; TOPICAL SKIN ADHESIVE

Model Number CHLOT01-08~TPMECC

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Insufficient information provided and at this time we are unable to confirm if the device caused or contributed to a serious injury.If further information becomes available a follow-up report will be submitted.

Event Description

The complainant reported that the registered nurse first assistant (rnfa) was getting ready to use liquiband octyl and something broke and pierced their finger.They thought it was some glass-like material.The nurse was double gloved and was concerned about possible contamination from the patient's blood.Both the nurse and the patient had blood drawn to check for blood-borne pathogens.The cut was cleaned out thoroughly and has fully healed.

• Brand Name: LIQUIBAND OCTYL
• Type of Device: TOPICAL SKIN ADHESIVE
• Manufacturer (Section D): ADVANCED MEDICAL SOLUTIONS LTD; western wood way; langage science park; plymouth, PL7 5 BG; UK PL7 5BG
• Manufacturer (Section G): ADVANCED MEDICAL SOLUTIONS LTD; western wood way; langage science park; plymouth, PL7 5 BG; UK PL7 5BG
• Manufacturer Contact: rebecca worthington ; western wood way; langage science park; plymouth, PL7 5-BG ; UK PL7 5BG
• MDR Report Key: 10563557
• MDR Text Key: 207888107
• Report Number: 9617175-2020-00031
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CHLOT01-08~TPMECC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1