Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL BNS 22GA 3-1/2IN WHITACRE; ANESTHESIA CONDUCTION NEEDLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD CARIBE LTD. NEEDLE SPINAL BNS 22GA 3-1/2IN WHITACRE; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 405157
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2020
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.(b)(4).
 
Event Description
It was reported that the needle spinal bns 22ga 3-1/2in whitacre package contained a "mastisol liquid adhesive" that had to be broken prior to opening the kit.The following information was provided by the initial reporter: "this package contained a mastisol liquid adhesive inside that had to broken prior to opening the kit.".
 
Manufacturer Narrative
Correction: per dchu, issue is not with a bd product.Therefore, the complaint will be cancelled.
 
Event Description
It was reported that the needle spinal bns 22ga 3-1/2in whitacre package contained a "mastisol liquid adhesive" that had to be broken prior to opening the kit.The following information was provided by the initial reporter: "this package contained a mastisol liquid adhesive inside that had to broken prior to opening the kit.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEEDLE SPINAL BNS 22GA 3-1/2IN WHITACRE
Type of Device
ANESTHESIA CONDUCTION NEEDLE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
MDR Report Key11248865
MDR Text Key229365721
Report Number2618282-2021-00005
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 02/04/2021
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? Yes
Device Operator Other
Device Expiration Date11/30/2022
Device Catalogue Number405157
Device Lot Number7317740
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/06/2021
Initial Date FDA Received01/28/2021
Supplement Dates Manufacturer Received02/04/2021
Supplement Dates FDA Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-