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

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 recz2019 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the guidewire of the accucath was extending from flash port, which prevented the safety mechanism from fully engaging/covering needle tip.
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 inability to activate the safety mechanism was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 2.25¿ accucath peripheral iv catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned for evaluation.The guidewire protruded from the flash notch.The safety button was depressed and the needle was partially withdrawn into the housing.The misrouted needle prevented complete withdrawal of the needle.Microscopic inspection of the needle bevel was unremarkable.Inspection of the needle tip revealed dried blood residue within the needle shaft.The guidewire protruding from the needle flash notch prevented activation of the safety mechanism.The wire can be forced through the notch if advancement is attempted against resistance, such as into tissue.A lot history review (lhr) of recz2019 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the guidewire of the accucath was extending from flash port, which prevented the safety mechanism from fully engaging/covering needle tip.

• Brand Name: ACCUCATH, 18 GX2.25
• 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: 10011473
• Report Number: 3006260740-2020-01559
• Device Sequence Number: 14177343
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/05/2020

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 Model Number: N/A
• Device Catalogue Number: AC0182250
• Device Lot Number: RECZ2019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1