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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. KIT PERISAFE 18GA 3-1/2IN WEISS ANESTHESIA CONDUCTION KIT

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BD CARIBE LTD. KIT PERISAFE 18GA 3-1/2IN WEISS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 400273
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem Underdose (2542)
Event Date 10/29/2020
Event Type  Injury  
Manufacturer Narrative
Date of birth: unknown. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0125364; medical device expiration date: 2025-04-30; device manufacture date: 2020-06-10. Medical device lot #: 0125374; medical device expiration date: 2025-04-30; device manufacture date: 2020-06-24. Medical device lot #: 0063313; medical device expiration date: 2025-02-28; device manufacture date: 2020-04-20. 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 kit perisafe 18ga 3-1/2in weiss graduation markings were missing, and the filter broke. The following information was provided by the initial reporter: error 1: the black mark on the catheter comes off with a simple wipe disinfection. Without the marking, the user can no longer see how far the catheter has to be inserted and complications can arise. Error 2: the filter contained in the set breaks when connecting. This error sometimes occurs when connecting for the first time. Sometimes the material tears, sometimes it splinters. In one specific case, the administration of pain medication during lung surgery in a nine-year-old female patient was not successful because the medication ran unnoticed next to the patient due to the damaged filter. This led to considerable complications. Patient safety is considerably endangered by this error.
 
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Brand NameKIT PERISAFE 18GA 3-1/2IN WEISS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
MDR Report Key10901846
MDR Text Key218573528
Report Number2618282-2020-00097
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K953790
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 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number400273
Device Catalogue Number400273
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/25/2020 Patient Sequence Number: 1
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