MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20GA, ACCUCATH IV CATHETER, 2.25", BASIC; INTRAVASCULAR CATHETER

Model Number AC0202250

Device Problems Break (1069); Flushing Problem (1252); Physical Resistance (2578); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Facility reported to the sales rep that during placement the coiled tip of the guidewire broke off inside the patient.It was stated by the healthcare professional (hcp) that the needle was visible, the wire was advanced, then catheter placed without difficulty.The hcp was able to get blood return; retraced needle.Hcp met resistance with the guidewire.Tugged slightly and noticed when the guidewire was removed the coiled tip of the wire was missing.Hcp was unable to flush; catheter was removed.Another device was used in a different location without any issues.The hcp compared the wire tips and realized the coiled tip was in fact missing from the initial device placed.X-ray of the arm is pending.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was two accucath peripheral iv catheter assemblies.Both assemblies were received with the needles retracted into the housings.One 20ga accucath catheter was also received.The catheter had been dissected into several segments and was received adhered to an adhesive dressing.Inspection of the first sample (sample 1) revealed a break in the guidewire proximal of the coil tip.Inspection of the second sample (sample 2) was unremarkable.Microscopic inspection of sample 2 confirmed the wire to be intact.Microscopic inspection of sample 1 confirmed a break in the guidewire.The distal tip including the preformed coil was not returned for evaluation.The wire exhibited a sharp bend in the vicinity of the break.The break surface exhibited a region of increased luster.Microscopic inspection of the needle bevel revealed mechanical damage.The sharp bend and increased luster were consistent with shearing type damage.Such damage can occur if the guidewire is withdrawn against the edge of a sharp object such as the introducer needle bevel.The product ifu states ¿do not force or retract the guidewire.Retracting the guidewire may increase the risk of guidewire damage.If the guidewire must be retracted, remove the entire device to prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.(b)(4).

Event Description

Facility reported to the sales rep that during placement the coiled tip of the guidewire broke off inside the patient.It was stated by the healthcare professional (hcp) that the needle was visible, the wire was advanced, then catheter placed without difficulty.The hcp was able to get blood return; retraced needle.Hcp met resistance with the guidewire.Tugged slightly and noticed when the guidewire was removed the coiled tip of the wire was missing.Hcp was unable to flush; catheter was removed.Another device was used in a different location without any issues.The hcp compared the wire tips and realized the coiled tip was in fact missing from the initial device placed.X-ray of the arm is pending.9/15/2017 - additional information reported that the coiled tip of the guidewire broke off and stuck in the patient.The physician was not able to remove it.11/20/2017 - sales representative confirmed that the guidewire fragment was successfully removed.

• Brand Name: 20GA, ACCUCATH IV CATHETER, 2.25", BASIC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6919201
• MDR Text Key: 88375089
• Report Number: 3006260740-2017-01789
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2017,02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2017
• Distributor Facility Aware Date: 09/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2017
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Disability
• Patient Age: 27 YR