MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 18GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx0282 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that wire would not thread and when they went to retract the needle, the needle wouldn¿t retract.The rn stated the wire did thread, but when catheter was advanced and pressed the safety button, it would not retract.Needle retracted once it was pulled out.
Event or Problem Description
It was reported that wire would not thread and when they went to retract the needle, the needle wouldn¿t retract.The rn stated the wire did thread, but when catheter was advanced and pressed the safety button, it would not retract.Needle retracted once it was pulled out.
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, 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 guidewire advancement was confirmed and the cause appeared to be use-related.The product returned for evaluation was one accucath peripheral iv catheter assembly.The catheter had been advanced and was not returned for evaluation.The safety button was depressed and the needle was fully withdrawn into the housing.The guidewire exhibited curved shape memory near the distal end.A sharp kink was observed in the coil region.Microscopic inspection of the guidewire confirmed a kink in the coil region of the guidewire.The wire was intact.Usage residues were observed.The kink in the coil region of the guidewire prevented complete retraction of the wire into the needle.The kink in the wire was consistent with attempted advancement against resistance, such as into tissue.The usage residues and event description suggested that occurred during device use.A lot history review (lhr) of recx0282 showed no other similar product complaint(s) from this lot number.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 18GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9788247
• Report Number: 3006260740-2020-00722
• Device Sequence Number: 16698163
• Product Code: FOZ
• UDI-Device Identifier: 00801741110993
• UDI-Public: (01)00801741110993
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: AC0182252
• Device Lot Number: RECX0282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1