• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

  • 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
 

ALCON RESEARCH, LLC - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 15717
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
 
Event Description
A nurse reported that the 30 gage cannulas do not fully lock with the 1cc/3cc syringes.The cannulas blew off syringes in the last two to three weeks.No patient impact reported.Additional information was requested; however, none has been received to date.
 
Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
As the customer did not retain the finished goods lot number, device history record (dhr) and lot history could not be reviewed.A sample was not returned for this complaint report; visual inspection or functional testing could not be conducted in order to establish a potential failure mode for the device.It is important to remind the customer to (at a minimum) provide an images of the alleged defective device or return the suspect sample for a full root cause evaluation.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CUSTOM-PAK SURGICAL PROCEDURE PACK
Type of Device
GENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
MDR Report Key8391578
MDR Text Key138089002
Report Number1644019-2019-00027
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 05/16/2019
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 Health Professional
Device Catalogue Number15717
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/13/2019
Initial Date FDA Received03/05/2019
Supplement Dates Manufacturer Received03/05/2019
05/14/2019
Supplement Dates FDA Received03/07/2019
05/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-