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

Model Number	AC0202250
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeu1917 showed three other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported insertion was successful, blood return, etc., with our primary iv team and within about 4 hours the iv won¿t flush.When removing the catheter there are not any kinks or bends and the lumen will not flush even after removal from the patient.Additional information provided 03/04/2021: it was reported the catheter placed quit working within 6 hours of placement, with blood return and flush being able to be completed upon insertion.When removed the catheter was not kinked or bent in anyway and would not flush at all after removal even with no evidence of occlusion in catheter tip.
Event or Problem Description
It was reported insertion was successful, blood return, etc., with our primary iv team and within about 4 hours the iv won¿t flush.When removing the catheter there are not any kinks or bends and the lumen will not flush even after removal from the patient.Additional information provided 03/04/2021: it was reported the catheter placed quit working within 6 hours of placement, with blood return and flush being able to be completed upon insertion.When removed the catheter was not kinked or bent in anyway and would not flush at all after removal even with no evidence of occlusion in catheter tip.
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 catheter would not flush was inconclusive since the affected sample was not returned for investigation.One sealed package with a 20g x 2.25¿ accucath catheter from lot #reeu1917 was returned for investigation.The packaging was opened and no damage or defects were observed on the returned sample.The catheter was removed from the needle and the valve actuator was noted to be in the correct position.Under microscopic examination, a syringe was attached to the luer adaptor and the valve actuator was pushed through the valve as designed.A functional test revealed that the catheter was patent to infusion and aspiration.The reported event could not be replicated on the unused sample that was returned for investigation; therefore, the complaint was inconclusive.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
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11576705
• Report Number: 3006260740-2021-01001
• Device Sequence Number: 3459982
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/06/2021

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: REEU1917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 06/04/2021
• 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