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

Model Number	AC0202250
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
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 reey2694 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via phone call "customer stating that the facility received item that was defective.He stated that the guidewires were sticking in the cannula when removing cannula from patient.No patient impact reported.".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 guidewire was sticking in the cannula was inconclusive and could not be demonstrated on the unused samples that were returned for investigation.Twenty-nine unopened accucath catheters from lot reey2694 were returned for investigation.Nine of the unused samples were removed from their packaging and a visual observation and microscopic examination of the catheter, needle bevel, and guidewire revealed nothing remarkable.A functional test of the samples revealed nothing remarkable.The guidewire could be advanced through and retracted within the needle.Each catheter was removed from the needle and guidewire without damage.The safety mechanism was activated without defect or difficulties.The size of the loop at the distal tip of the guidewire was within specification.Since the affected sample was not returned for investigation and since no damage was observed or replicated on the returned samples, the complaint was inconclusive.H3 other text : device evaluation findings are in the manufacturer's note.
Event or Problem Description
It was reported via phone call "customer stating that the facility received item that was defective.He stated that the guidewires were sticking in the cannula when removing cannula from patient.No patient impact reported.".

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12011332
• Report Number: 3006260740-2021-02333
• Device Sequence Number: 3197086
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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 Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: REEY2694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 09/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2020
• 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