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: ARTHREX, INC. ARTHREX ACP DOUBLE SYRINGE SYSTEM; SYRINGE, PISTON
  • 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
 

ARTHREX, INC. ARTHREX ACP DOUBLE SYRINGE SYSTEM; SYRINGE, PISTON Back to Search Results
Model Number ARTHREX ACP DOUBLE SYRINGE SYSTEM
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/23/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event or Problem Description
On (b)(6) 2021, it was reported by a distributor via sems that an abs-10010s double syringe leaked rpr from plunger during injection.This was discovered during prp therapy.Surgeon completed case successfully using another double syringe; patient was not affected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARTHREX ACP DOUBLE SYRINGE SYSTEM
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key12616631
Report Number1220246-2021-03785
Device Sequence Number3973284
Product Code FMF
UDI-Device Identifier00888867083790
UDI-Public00888867083790
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
BK070069
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 10/12/2021
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
Operator of Device Health Professional
Device Expiration Date01/31/2025
Device Model NumberARTHREX ACP DOUBLE SYRINGE SYSTEM
Device Catalogue NumberABS-10010S
Device Lot Number1018109429
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/23/2021
Initial Report FDA Received Date10/12/2021
Patient Sequence Number1
-
-