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: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD OEM LARGEBORE SMARTPOCKET; 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
 

SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD OEM LARGEBORE SMARTPOCKET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 5600R
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Event Description
It was reported 2000 bd oem largebore smartpockets had foreign material.The following information was provided by the initial reporter: "customer observed that the lot of (b)(4) units contains unknown residue inside the valve body.".
 
Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: ten customer samples were received at jan 24th, 2022 in tijuana site to visually confirm the suspected unknown residue.The visual inspection performed through the mrb team suggested that effectively the samples look like a certain residue inside of the largebore smartpocket s/a (p/n 620-00170) around the ss piston sandy (p/n tc10011048).The suspected residue is the dow 550 silicone fluid (item 4) p/n 640052 applied during station # 3 on combo # 5 (pe-0606-002).The silicone fluid is a key material applied directly on the piston sides.A gemba walk was performed by the mrb team throughout the combo # 5 machine to confirm the proper silicone fluid on the piston sides.The investigation suggested that effectively the fluid residue material that the customer sample states correspond to the silicone fluid p/n 640052 applied during station # 3 on combo # 5 (pe-0606-002).Dhr was performed and no qn's were identified.After the investigation and according to the mrb team (manufacturing and quality operations), it was not possible to confirm the failure mode stated by the customer.The suspected unknown residue or foreign material found inside of the largebore smartpocket s/a (p/n 620-00170) and around the ss piston sandy (p/n tc10011048) is exactly the dow 550 silicone fluid p/n 640052 which is part of the bill of material (bom) for subassembly p/n 620-00170.The biological and toxicological testing performed for smartsite components met the requirements as specified.H3 other text : see h10.
 
Event Description
It was reported 2000 bd oem largebore smartpockets had foreign material.The following information was provided by the initial reporter: "customer observed that the lot of (b)(4) units contains unknow residue inside the valve body.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD OEM LARGEBORE SMARTPOCKET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13345607
MDR Text Key284390063
Report Number9616066-2022-00023
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/22/2022
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 Catalogue Number5600R
Device Lot Number21028808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/06/2022
Initial Date FDA Received01/25/2022
Supplement Dates Manufacturer Received04/22/2022
Supplement Dates FDA Received04/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-