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 N/A

Device Problems Material Frayed (1262); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/26/2022

Event Type  Injury  

Event Description

It was reported "attempted to place accucath- fed integrated accucath wire and had some resistance- then aborted case.When removed device recognized wire gone- xray and follow up studies showed wire in patient- vascular surgeon consulted for assessment - pt stable." add info received on 06/02/2022: x-ray of right arm was performed.Did the patient require surgery to remove the broken piece? no, vascular surgery team determined that the patient was not a candidate for surgery.Were all the missing/broken pieces retrieved and accounted for? broken piece remains as foreign body in patient.Any long-term patient harm? if yes, please describe the harm, how it was treated and the outcome.No long-term patient harm documented as this moment.

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx5467 showed no other similar product complaint(s) from this lot number.

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 difficult catheter insertion and guidewire damage 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 guidewire slider was extended but the guidewire was not visible extending from the needle.The catheter exhibited a sharp kink approximately 1cm from the distal tip.The tip appeared irregular.The guidewire was removed from the needle shaft.The guidewire was broken proximal of the tapered region.The distal fragment was not returned for evaluation.Microscopic inspection of the guidewire break site revealed a dully granular fracture surface.Curved shape memory and necking were visible in the vicinity of the break.Microscopic inspection of the distal end of the catheter confirmed deformation.The tip appeared crumpled and torn.Inspection of the needle revealed deformation along the proximal edge of the bevel.The catheter damage was consistent with attempted insertion against resistance, such as into tissue.The guidewire break features were consistent with material failure due to tensile (pulling) and/or bending stresses.It appeared that resistance was encountered during insertion/removal, leading to guidewire fracture.The needle bevel damage suggested that retraction of the wire against the needle may have contributed.

Event Description

It was reported "attempted to place accucath- fed integrated accucath wire and had some resistance- then aborted case.When removed device recognized wire gone- xray and follow up studies showed wire in patient- vascular surgeon consulted for assessment - pt stable." add info received on 06/02/2022: x-ray of right arm was performed.Did the patient require surgery to remove the broken piece? no, vascular surgery team determined that the patient was not a candidate for surgery.Were all the missing/broken pieces retrieved and accounted for? broken piece remains as foreign body in patient.Any long-term patient harm? if yes, please describe the harm, how it was treated and the outcome.No long-term patient harm documented as this moment.

• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14737316
• MDR Text Key: 294493080
• Report Number: 3006260740-2022-02341
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741137952
• UDI-Public: (01)00801741137952
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AC1202250
• Device Lot Number: REFX5467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 133 KG