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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM BACTISEAL BARIUM STRIPED CATH BACTISEAL CATHETER KIT

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RAYNHAM BACTISEAL BARIUM STRIPED CATH BACTISEAL CATHETER KIT Back to Search Results
Catalog Number NS0340
Device Problem Obstruction of Flow (2423)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that shunt system implanted to the patient on (b)(6) 2019. Certas plus valve and bactiseal catheter kit. The patient was experiencing symptoms of hydrocephalus and upon examination it was determined the system wasn¿t flowing. The patient was brought back to surgery on (b)(6) 2019 for revision where it was determined that the ventricular catheter was clogged and not draining. The ventricular catheter was replaced with item ns0338 and the system resumed working.
 
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Brand NameBACTISEAL BARIUM STRIPED CATH
Type of DeviceBACTISEAL CATHETER KIT
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA 02767
Manufacturer Contact
vivian nelson
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key9167385
MDR Text Key161804412
Report Number1226348-2019-00462
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K031123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Catalogue NumberNS0340
Device Lot NumberJ2792D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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