MAUDE Adverse Event Report: ACCUCATH, 18GX1.25 BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
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 reex1792 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "last week, upon retracting the needle, a plastic piece came out with the end of the wire." no other information was provided.
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 flow actuator dislodgement was confirmed; however, the root cause was not identified.The product returned for evaluation was one 18ga x 1.25¿ accucath peripheral iv catheter assembly.The catheter had been advanced and was received separate from the assembly.An extension tube was attached to the catheter luer adapter.The safety button was pressed and the needle was fully withdrawn into the housing.The flow actuator was detached from the catheter and remained overlaying the guidewire.An attempt to infuse water through the catheter using a 12ml syringe revealed it to be fully occluded due to the detached flow actuator.Microscopic inspection of the flow actuator revealed it to be well-formed.The actuator was measured using a digital microscope and found to be within manufacturing specifications.While the flow actuator was confirmed to have become dislodged from the catheter luer, the cause of that dislodgement was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.
Event or Problem Description
It was reported "last week, upon retracting the needle, a plastic piece came out with the end of the wire." no other information was provided.

• Brand Name: ACCUCATH, 18GX1.25 BASIC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12580704
• Report Number: 3006260740-2021-04146
• Device Sequence Number: 1239629
• Product Code: FOZ
• UDI-Device Identifier: 00801741110900
• UDI-Public: (01)00801741110900
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: AC0181250
• Device Lot Number: REEX1792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 10/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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