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

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of regr0489 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "inserted without difficulty but was unable to be removed due to kink in catheter." additional information received 08/12/2022: "the vein was the patient¿s right cephalic in their lower arm.My insertion point was 3 or 4 inches proximal to the patient¿s wrist, more towards the posterior side of the arm.The vein was about.25cm depth, very shallow.I placed the accucath with ultrasound and visualized the needle tip entering the vein.The insertion itself went very smooth and immediate blood flash was seen in the catheter.The initial poke was made without a tourniquet, but once i was in the vein and proceeding to walk the needle up the vein, noted it was too superficial and easily compressible for me to continue walking the needle or advance the guidewire.The patient¿s arm was stabilized in the bed with a pillow and flat, so i let go of the needle and probe to tie the tourniquet.No movement of the needle occurred during the time i was not holding it.After the tourniquet was tied, i resumed placement and visualized the needle to be firmly inside of the vein.I walked the needle up ¾ of the length of the catheter.Tip was visualized throughout this and vein wall was not touched or snagged.No resistance was felt.At this point i advance the guidewire and was met with no resistance.I dropped the probe, held the pink catheter hub in my left hand and guidewire handle in my right.I advance the catheter with my left hand, while guidewire was still fully extended, and met no resistance.Maintaining a hold on the pink catheter hub, i pulled back slightly on the guidewire handle to remove the needle around an inch, and then activated the needle safety.The needle retracted with only slight resistance against the catheter, a small amount of friction i will feel fairly often when inserting these.At this point i attempted the flush the catheter after attaching a flush.The catheter was 100% occluded and had no give when attempting to flush.I visualized the catheter tip at this time under ultrasound to assess for problems.I saw the catheter side by side for about 1-2cm at the tip, appearing to have double backed on itself.At that time i applied gentle flushing pressure and slowly retracted the catheter to hopefully achieve patency after the catheter had straightened.At no point during this retraction method with continued flush pressure did i feel any give on the plunger.It appeared to be 100% occluded throughout attempting this.I planned to fully remove the catheter at this point as it appeared it would not function.Upon attempting removal, i met resistance near the last couple centimeters of catheter.It was pulling the patient¿s skin, attempted to be bunched up, and a small ¿knot¿ was felt in the catheter upon palpation.I immediately had the covering providers come to bedside.We looked at the catheter under ultrasound and attempted removal using a combination of flushing and repositioning.The catheter was unable to be removed.Catheter hub was capped with a green cap, covered with tegaderm per the provider, and bedside nursing was told not to use it.Vascular surgery was consulted.When vascular surgery arrived an hour later, they removed the catheter with minimal force.".

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 a kinked catheter was confirmed.The product returned for evaluation was one 20ga x 2.25¿ accucath ace peripheral iv catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was received loose.The safety button was depressed and the needle was fully withdrawn into the housing.The wire exhibited curved shape memory near the distal end.The catheter exhibited multiple bends and kinks near the distal end.Microscopic inspection of the catheter confirmed multiple kinks near the distal end.Buckling was observed at the distal end.The edges of the catheter flared outward.Microscopic inspection of the guidewire revealed slight misalignment of the coils.The guidewire shape memory, coil misalignment, catheter tip deformation and catheter kinking/buckling were all consistent with damage caused by insertion against resistance, such as into tissue.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported "inserted without difficulty but was unable to be removed due to kink in catheter." additional information received 08/12/2022: "the vein was the patient¿s right cephalic in their lower arm.My insertion point was 3 or 4 inches proximal to the patient¿s wrist, more towards the posterior side of the arm.The vein was about.25cm depth, very shallow.I placed the accucath with ultrasound and visualized the needle tip entering the vein.The insertion itself went very smooth and immediate blood flash was seen in the catheter.The initial poke was made without a tourniquet, but once i was in the vein and proceeding to walk the needle up the vein, noted it was too superficial and easily compressible for me to continue walking the needle or advance the guidewire.The patient¿s arm was stabilized in the bed with a pillow and flat, so i let go of the needle and probe to tie the tourniquet.No movement of the needle occurred during the time i was not holding it.After the tourniquet was tied, i resumed placement and visualized the needle to be firmly inside of the vein.I walked the needle up ¾ of the length of the catheter.Tip was visualized throughout this and vein wall was not touched or snagged.No resistance was felt.At this point i advance the guidewire and was met with no resistance.I dropped the probe, held the pink catheter hub in my left hand and guidewire handle in my right.I advance the catheter with my left hand, while guidewire was still fully extended, and met no resistance.Maintaining a hold on the pink catheter hub, i pulled back slightly on the guidewire handle to remove the needle around an inch, and then activated the needle safety.The needle retracted with only slight resistance against the catheter, a small amount of friction i will feel fairly often when inserting these.At this point i attempted the flush the catheter after attaching a flush.The catheter was 100% occluded and had no give when attempting to flush.I visualized the catheter tip at this time under ultrasound to assess for problems.I saw the catheter side by side for about 1-2cm at the tip, appearing to have double backed on itself.At that time i applied gentle flushing pressure and slowly retracted the catheter to hopefully achieve patency after the catheter had straightened.At no point during this retraction method with continued flush pressure did i feel any give on the plunger.It appeared to be 100% occluded throughout attempting this.I planned to fully remove the catheter at this point as it appeared it would not function.Upon attempting removal, i met resistance near the last couple centimeters of catheter.It was pulling the patient¿s skin, attempted to be bunched up, and a small ¿knot¿ was felt in the catheter upon palpation.I immediately had the covering providers come to bedside.We looked at the catheter under ultrasound and attempted removal using a combination of flushing and repositioning.The catheter was unable to be removed.Catheter hub was capped with a green cap, covered with tegaderm per the provider, and bedside nursing was told not to use it.Vascular surgery was consulted.When vascular surgery arrived an hour later, they removed the catheter with minimal force.".

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER (20G)
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15280005
• MDR Text Key: 305432294
• Report Number: 3006260740-2022-03273
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REGR0489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other