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 Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reex2308 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported ¿the accucath iv cath-tip came off upon removal.While attempting iv access on a pt yesterday with a 2.25cm angio cath, visualization was made inside the vessel, the guide wire was inserted with no complications, and i attempted to thread the catheter and was then met with considerable resistance half way through insertion.I stopped progress and retracted the guide wire and needle, heard and felt the audible click.I then attempted to remove the catheter and again was met with considerable resistance.With slow and gentle pressure, i started to remove the catheter and it gave way and i noticed the end had a tear on it.After comparing the catheter to a new one, i could see that a portion was missing.I was able to place the probe back on the insertion site and i could visualize a piece of the catheter.I informed the physician immediately and showed her the catheter.She then called ir to place a pic line and to remove the remaining catheter.A little while later she informed me that the catheter had broken in soft tissue and not the vessel, and that a portion of the wire was also found.After retracting the wire and needle, i had placed it in the sharps container and unfortunately did not see that a portion of wire was also missing.I informed the anm on duty and removed the remaining catheters with the same lot number.".
Event or Problem Description
It was reported ¿the accucath iv cath-tip came off upon removal.While attempting iv access on a pt yesterday with a 2.25cm angio cath, visualization was made inside the vessel, the guide wire was inserted with no complications, and i attempted to thread the catheter and was then met with considerable resistance half way through insertion.I stopped progress and retracted the guide wire and needle, heard and felt the audible click.I then attempted to remove the catheter and again was met with considerable resistance.With slow and gentle pressure, i started to remove the catheter and it gave way and i noticed the end had a tear on it.After comparing the catheter to a new one, i could see that a portion was missing.I was able to place the probe back on the insertion site and i could visualize a piece of the catheter.I informed the physician immediately and showed her the catheter.She then called ir to place a pic line and to remove the remaining catheter.A little while later she informed me that the catheter had broken in soft tissue and not the vessel, and that a portion of the wire was also found.After retracting the wire and needle, i had placed it in the sharps container and unfortunately did not see that a portion of wire was also missing.I informed the anm on duty and removed the remaining catheters with the same lot number.".
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 of a damaged catheter and guidewire was confirmed.A total of nine accucath catheters were returned for an investigation.Seven of the nine accucath catheters were unused and received in sealed packages.Two of the nine catheters returned were received outside their packaging and appeared to be used.What appeared to be blood residue was observed throughout each used catheter.One of the used catheters was broken 3.9 cm from the distal end of the purple oversleeve.The loose catheter segment was 1.9 cm in length.A microscopic observation of the adjoining ends of the broken catheter revealed deformation and fraying of the catheter material.Score lines and a puncture were observed within the distal segment of tubing, which indicates that the needle may have damaged the catheter.Indentations were observed 1.1 cm from the distal tip of the distal catheter segment, which may have been created when retrieving the broken catheter segment.The valve actuator had not been engaged in the catheter connector.The distal segment of guidewire was also returned for the investigation.The length of the guidewire is equal to the distance a guidewire will extend from the needle.The coiled end of the guidewire was present at the distal tip.The broken end of the guidewire was slightly bent.The cross section was granular, and a portion of the edge exhibited increased luster, which indicates that the guidewire may have been damaged by the needle bevel.The remaining samples exhibited no damage or functional defects.The damage observed on the used sample may have been caused by inadvertent complications during the insertion process.The instructions for use (ifu) state, ¿warning: once the catheter has been advanced, do not reinsert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ no further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.

• 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: 11426774
• Report Number: 3006260740-2021-00708
• Device Sequence Number: 11772492
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: REEX2308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 76