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

Model Number AC1202250

Device Problems Material Frayed (1262); Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reev1228 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by placer "i went to place an ultrasound iv.The patient had a decent antecubital vein.I got into the vein and it was a little tough-felt like a lot of scar tissue.I continued to walk my catheter into the vein.First attempt to slide wire was unsuccessful.I slid the wire back and continued to walk my catheter in.I then advanced my wire which felt smooth.Next went my catheter which was hard to advance about half in.Then tried to pull back my wire, which the pink slide busted off/slipped up.I retracted my needle with my white button which seemed to go fine.I could see my wire in the plastic part of the whole unit and my needle but the end of the catheter that is curled wasn¿t at the end so i was unsure what was left in the patient.The catheter remained in the patient and i couldn¿t pull it out.I asked the md to assist.He used lidocaine and pulled hard, and upon removal, the wire was partially in the patient along with the catheter." additional information received 1/17/2021: it was reported this incident was painful for the patient.The catheter and wire were retrieved from the patient's arm with lidocaine and 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 insertion complication when attempting accucath catheter placement was confirmed.The product returned for evaluation was three photographs depicting a 20ga x 2.25¿ accucath peripheral iv catheter assembly.The photographs depicted the housing, guidewire and catheter.Usage residues were evident throughout the device.The guidewire was fractured within the nitinol region.The catheter appeared to be kinked and perforated approximately 2cm from the distal tip.The safety button was depressed and the wire was withdrawn into the housing.The guidewire slider appeared to have been pulled partially away from the housing.The catheter, guidewire and housing features were all consistent with the report of a difficult insertion procedure.The catheter damage appeared consistent with perforation by the introducer needle during withdrawal onto the housing.The wire deformation and fracture appeared consistent with attempted insertion against resistance, such as into tissue, followed by retraction against the needle bevel.The guidewire advancer was consistent with guidewire retraction against resistance, such as against the needle bevel.Combined, these features suggested that initial insertion of both the wire and the catheter may have been attempted against resistance, or at a steep insertion angle.Subsequent withdrawal of both components against the needle may have led to damage.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported by placer "i went to place an ultrasound iv.The patient had a decent antecubital vein.I got into the vein and it was a little tough-felt like a lot of scar tissue.I continued to walk my catheter into the vein.First attempt to slide wire was unsuccessful.I slid the wire back and continued to walk my catheter in.I then advanced my wire which felt smooth.Next went my catheter which was hard to advance about half in.Then tried to pull back my wire, which the pink slide busted off/slipped up.I retracted my needle with my white button which seemed to go fine.I could see my wire in the plastic part of the whole unit and my needle but the end of the catheter that is curled wasn't at the end so i was unsure what was left in the patient.The catheter remained in the patient and i couldn't pull it out.I asked the md to assist.He used lidocaine and pulled hard, and upon removal, the wire was partially in the patient along with the catheter." additional information received 1/17/2021: it was reported this incident was painful for the patient.The catheter and wire were retrieved from the patient's arm with lidocaine and force.

• Brand Name: ACCUCATH, ACE 20GX2.25
• 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: 11207648
• MDR Text Key: 229310019
• Report Number: 3006260740-2021-00045
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741137952
• UDI-Public: (01)00801741137952
• Combination Product (y/n): N
• PMA/PMN Number: K162894
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC1202250
• Device Catalogue Number: AC1202250
• Device Lot Number: REEV1228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR