MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN; BACTISEAL CATHETER KIT

Catalog Number XXX- BACTISEAL CATHETER

Device Problem Infusion or Flow Problem (2964)

Patient Problem Fever (1858)

Event Type  Injury  

Manufacturer Narrative

The bactiseal was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.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.

Event Description

2 of 2 reports.Other mfg report number: 3013886523-2021-00220 a facility reported: "the valve was implanted to the patient about 2 month ago with unknown setting.It was used with bactiseal(serial:unk).The patient had pneumonia / urinary tract infection before the implant, but after it had subsided, surgery was performed.Infectious symptoms such as fever developed 3 weeks after surgery and a cerebrospinal fluid test shows that the protein has increased, but the number of cells has not increased.Hematoma remains in the ventricles of patient with intraventricular hemorrhage.Implantation of a shunt resulted in overdrainage and was likely to result in subdural hematoma.According to the doctor, it is not determined that it is a shunt infection." it is unknown what type of treatment/medications were provided.

• Brand Name: UNKNOWN
• Type of Device: BACTISEAL CATHETER KIT
• 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: 11967176
• MDR Text Key: 255158825
• Report Number: 3013886523-2021-00257
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX- BACTISEAL CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2021
• 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