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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.
 
Event Description
N/a.
 
Manufacturer Narrative
The bactiseal barium striped was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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.
 
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Brand Name
BACTISEAL BARIUM STRIPED CATH
Type of Device
BACTISEAL CATHETER KIT
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
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
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Expiration Date01/31/2020
Device Catalogue NumberNS0340
Device Lot NumberJ2792D
Was Device Available for Evaluation? No
Date Manufacturer Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
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