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 N/A

Device Problems Difficult to Flush (1251); Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

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 (reeu1917) have been reported from the same facility.

Event Description

It was reported ''we used 4 out this box with successful insertion, 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." this report addresses the first of the four devices.

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.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported " we used 4 out this box with successful insertion, 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." this report addresses the first of the four devices.Additional information provided 03/04/2021: "all of the guideline catheters 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.".

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• Type of Device: 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: 11385721
• MDR Text Key: 238351705
• Report Number: 3006260740-2021-00505
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (y/n): N
• PMA/PMN Number: K153298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AC0202250
• Device Lot Number: REEU1917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other