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	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
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 "needle retraction system did not work as intended.Spring was not able to function properly and retract needle." it was stated the device was contaminated with blood and was disposed of.
Event or Problem Description
It was reported "needle retraction system did not work as intended.Spring was not able to function properly and retract needle." it was stated the device was contaminated with blood and was disposed of.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the needle retraction spring not functioning as intended was confirmed; however, the root cause was not identified.The product returned for evaluation was three photographs depicting a 2.25¿ accucath peripheral iv catheter assembly.The catheter had been advanced and was not visible in any of the photographs.Two of the photographs depicted the needle, which extended from the housing.Blood residue was evident on the needle shaft.The remaining photograph depicted the guidewire slider fully withdrawn into the housing.The needle carrier appeared to partially withdrawn into the housing.The distal end of the spring was visible just above the needle carrier and was not pressed against the distal end of the housing.The spring appeared to be caught on the needle carrier.Interference between the spring and the needle carrier appeared to cause or contribute to the observed spring mis-location; however, inspection of the submitted photographs was insufficient to identify the cause of that interference.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.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: 11930601
• Report Number: 3006260740-2021-02130
• Device Sequence Number: 4381319
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/11/2021

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: 05/18/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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