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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM PROG VALVE INLINE W SG; CHPV WITH SG

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RAYNHAM PROG VALVE INLINE W SG; CHPV WITH SG Back to Search Results
Catalog Number 823162
Device Problem Infusion or Flow Problem (2964)
Patient Problems Injury (2348); Lethargy (2560)
Event Date 07/17/2020
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
A surgeon reported the hakim valve was not flushing and was revised/explanted.The valve was implanted on (b)(6) 2020 and on (b)(6) 2020 the patient presented with lethargy and emesis; there was no runoff thru the valve and the surgeon could not flush anything thru the valve; therefore, it was explanted and replaced with a new hakim.
 
Manufacturer Narrative
Updated fields - d1, d2, d4, d10, g4, g7, h2, h3, h4, h6, h10.Unique device identifier (udi) : (b)(4).The hakim valve was returned for evaluation: review of the history device records for the valve, product code 82-3162 with lot 3621625, conformed to the specifications when released to stock on the 23rd april 2019.Failure analysis - the valve was visually inspected, no defects noted.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.The valve passed the for programming, occlusion, leaks, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up this could interfere with the valve mechanism, but at the time of investigation no issues were noted.
 
Event Description
N/a.
 
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Brand Name
PROG VALVE INLINE W SG
Type of Device
CHPV WITH SG
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key10465625
MDR Text Key204729147
Report Number3013886523-2020-00059
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Catalogue Number823162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Initial Date Manufacturer Received 07/18/2020
Initial Date FDA Received08/28/2020
Supplement Dates Manufacturer Received10/09/2020
Supplement Dates FDA Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age6 YR
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