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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. BD KIT PERISAFE 18GA 3-1/2IN WEISS; ANESTHESIA CONDUCTION KIT
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BD CARIBE LTD. BD KIT PERISAFE 18GA 3-1/2IN WEISS; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 400273
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported when using the bd kit perisafe 18ga 3-1/2in weiss the catheter broke apart.The following information was provided by the initial reporter.The customer stated: "when the anesthesiologist inserted perisafe in the patient and while removing the epidural needle, the tip of the epidural catheter got cut around 1 cm.The dr was suspecting the tip of the epidural catheter remains in the patient while removing it.However post operation, they will perform a xray and ct scan." no further information provided at this time.
 
Event Description
It was reported when using the bd kit perisafe 18ga 3-1/2in weiss the catheter broke apart.The following information was provided by the initial reporter.The customer stated: "when the anesthesiologist inserted perisafe in the patient and while removing the epidural needle, the tip of the epidural catheter got cut around 1 cm.The dr was suspecting the tip of the epidural catheter remains in the patient while removing it.However post operation, they will perform a xray and ct scan." no further information provided at this time.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 1/10/2022.H6: investigation: based on the sample provided to bd for evaluation, the reported condition was verified.The manufacturing facility has been notified of this incident and no discrepancy or non-conformance were identified that could have contributed to the reported condition.A review of the device history record was performed, and no quality issues were found during production.After investigation and evaluation of the dhr documents, it was found manufacturing of the needle complies with bd specifications.The catheter material passed incoming inspection in which includes visual, dimensional, and functional testing and lots were released with acceptable results.No indications on inspections reports nor dhr reviews related to reported defect.Packaging process was found in compliance.Instructions included in the ifu states as follows in the procedure section - step #3: to avoid damage to the catheter, do not withdraw the catheter through the needle once the catheter has passed beyond the epidural needle tip.
 
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Brand Name
BD KIT PERISAFE 18GA 3-1/2IN WEISS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer (Section G)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13006333
MDR Text Key284838370
Report Number2618282-2021-00077
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier30382904002733
UDI-Public30382904002733
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K953790
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number400273
Device Catalogue Number400273
Device Lot Number0302097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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