MAUDE Adverse Event Report: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refn1107 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "plastic catheter sheared during advancement.Plastic catheter was removed with no break occurring in patient.".
Event or Problem Description
It was reported "plastic catheter sheared during advancement.Plastic catheter was removed with no break occurring in patient.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the catheter sheared during advancement was inconclusive since the damaged catheter was not returned for investigation.Seven unopened accucath catheters from lot reeu0575, one accucath deployment system in an open kit from lot reeu0575, and one package from lot refn1107 were returned for investigation.The safety mechanism on the used deployment system had been activated and the catheter was not returned for investigation.The safety mechanism was deactivated and the needle was advanced from the handle.A microscopic examination of the needle bevel revealed nothing remarkable.Five of the seven sealed samples were removed from their packaging.The catheters were removed from the needle without damage.The safety mechanism on the unused samples was activated without difficulties.No evidence of the reported event was observed on the returned samples.Since the damaged catheter was not returned for investigation, the complaint was inconclusive.Potential contributing factors include retraction of the catheter over the needle bevel.The instructions for use (ifu) warns, ¿once the catheter has been advanced, do not reinsert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ h3 other text : evaluation findings are in section h.11.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 11930771
• Report Number: 3006260740-2021-02131
• Device Sequence Number: 4381321
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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 Model Number: N/A
• Device Catalogue Number: AC0202250
• Device Lot Number: REFN1107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other