MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH 20 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	AC0202250
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unable to retract guidewire is confirmed but the exact cause remains unknown.Three photo samples of an accucath device were provided for evaluation.The first photo shows the catheter with the guidewire present internally.The catheter is wrinkled and damaged forming a ¿j¿ shape.The coiled guidewire tip appears to be bending against the catheter tip.The second image shows the entire device.The catheter is still present near the housing and the needle appears to have been retracted.The third image shows the product label which indicates lot: reey2674.Based on the photo sample provided, possible contributing factors include kinking or deformation of the guidewire during insertion.The guidewire appears to have deformed around the catheter contributing to the interference during retraction.Since the reported issue was observed in the images provided, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of reey2674 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the guidewire would not retract.No other information was provided.6/10/2021: the returned device was found kinked.

• Brand Name: ACCUCATH 20 GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12093703
• Report Number: 3006260740-2021-02489
• Device Sequence Number: 4581674
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 06/11/2021

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: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: REEY2674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 122