MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL EVD CATHETER; BACTISEAL EVD CATHETERS

Model Number 821745

Device Problem Difficult to Remove (1528)

Patient Problem Laceration(s) (1946)

Event Date 10/14/2022

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the silicon cover over the trocar of a bactiseal catheter (id 821745) was very difficult to remove causing a sharp injury to a theatre scrub nurse.

Manufacturer Narrative

The bactiseal catheter (id 821745) was not returned for evaluation (as per customer, product not available).Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to an issue with the silicone cover or the trocar.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Additional information received: incident date - (b)(6) 2022.Describe the type of injury and its site ¿ injury broke the glove but not skin.Extension of the injury not serious, no injury to skin.What steps were taken for the nurse who received the injury and was she ok following the incident immediate first aid care ¿ wash wound, no further care required.How is the scrub nurse doing? scrub nurse is okay.She is undergoing testing as per the hospitals protocol.

Event Description

N/a.

• Brand Name: CODMAN BACTISEAL EVD CATHETER
• Type of Device: BACTISEAL EVD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15749730
• MDR Text Key: 303224935
• Report Number: 3013886523-2022-00532
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780515593
• UDI-Public: (01)10381780515593(17)221231(10)6058695
• Combination Product (y/n): N
• PMA/PMN Number: K102589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 821745
• Device Catalogue Number: 821745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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