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: AS LVP BLD180M 15D DEHP; INTRAVASCULAR ADMINISTRATION SET
  • 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
 

AS LVP BLD180M 15D DEHP; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 10015414
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: (b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 19016977.Medical device expiration date: 2022-01-28.Device manufacture date: 2019-01-26.Medical device lot #: 19045971.Medical device expiration date: 2022-04-09.Device manufacture date: 2019-04-09.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 that 2 as lvp bld180m 15d dehp experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: i have received a notice that the blood administration sets appear to be turning a orange/red color within the tubing and filter area.
 
Manufacturer Narrative
H.6.Investigation: two samples were received for quality investigation.The customers complaint of cosmetic issue - discolored was verified by visual inspection.Evaluation of the samples submitted showed that the samples had a dark tint in the tubing that was throughout the infusion sets.A device history record review for model 10015414 lot number 19016977 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 10015414 lot number 19045971 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this issue seen in this complaint is the sterilization process.Due to the sterilization process the infusion set tubing can get tinted.Additionally, the tinting of the tubing can be more visible throughout the infusion set with time.The discoloration does not affect the functionality and/or safety of the device.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of cosmectic issue - discolored with lot #19016977 regarding item #10015414.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of cosmectic issue - discolored with lot #19045971 regarding item #10015414.H3 other text : see h.10.
 
Event Description
It was reported that 2 as lvp bld180m 15d dehp experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: i have received a notice that the blood administration sets appear to be turning a orange/red color within the tubing and filter area.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AS LVP BLD180M 15D DEHP
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12502665
MDR Text Key272463565
Report Number9616066-2021-52092
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403233997
UDI-Public50885403233997
Combination Product (y/n)N
PMA/PMN Number
K894842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number10015414
Device Catalogue Number10015414
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-