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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANESTHESIA KIT PERISAFE VI CAL 18 ANESTHESIA CONDUCTION KIT

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANESTHESIA KIT PERISAFE VI CAL 18 ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 400722
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that anesthesia kit perisafe vi cal 18 was damaged, but still operable. The following information was provided by the initial reporter: "(b)(6) 2020: the locking equipment delivered by plarre was sealed, a mixed block was placed with the introduction of an epidural catheter by a tohuy needle without complications at the time of removal of the tohuy needle, resistance was perceived, and a defect was observed in catheter in the distal portion, so it was decided not to force the catheter and total removal of the equipment. As immediate actions, the equipment was removed without forcing an epidural catheter together with a tohuy needle, leaving the procedure without a backup dose for analgesia, mentioning that the defect had a great potential for risk to life and complications for this patient. Product data: material: (b)(4), description: block kit 18 perisafe vi bd, lot: 9246162. ".
 
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Brand NameANESTHESIA KIT PERISAFE VI CAL 18
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
MDR Report Key10591227
MDR Text Key214379476
Report Number9610847-2020-00300
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/01/2021
Device Catalogue Number400722
Device Lot Number9246162
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/27/2020 Patient Sequence Number: 1
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