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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS ACCESS; SET, ADMINISTRATION, INTRAVASCULAR
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BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS ACCESS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number VMC9607C
Device Problems Leak/Splash (1354); Chemical Spillage (2894)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2014
Event Type  malfunction  
Event Description
It was reported that a light sensitive drug set leaked.This malfunction occurred during use.There was no patient injury, medical intervention or adverse event associated with this event.Additional information was requested and is not available.
 
Manufacturer Narrative
(b)(4).If additional relevant information is obtained, then a follow-up mdr will be submitted.
 
Manufacturer Narrative
(b)(4).The exact age of the patient is unknown; however, the patient was reported to be a (b)(6).It was reported that a parental nutrition bag was used at the time of the event and the device was used with an single-channel infusion pump.) evaluation summary: the customer did not return the actual sample; however, they did provide a photograph.A photographic inspection identified that there was a hole in the tubing.The cause of the condition was not determined.A capa has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
ACCESS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
route de chebbaou
2021oued e
tunis
TS 
Manufacturer (Section G)
BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
route de chebbaou
2021oued e
tunis
TS  
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3942434
MDR Text Key4579870
Report Number1416980-2014-23083
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2018
Device Catalogue NumberVMC9607C
Device Lot Number14A06V068
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
PARENTAL NUTRITION BAG, SINGLE-CHANNEL PUMP
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