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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
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 refu1390 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "needle would not safety." additional info.Received (b)(6) 2022: accucath placed without difficulty, when button depressed to safety needle, it would not retract.Button was fully depressed.No patient harm.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refu1390 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "needle would not safety." additional info.Received (b)(6) 2022: accucath placed without difficulty, when button depressed to safety needle, it would not retract.Button was fully depressed.No patient harm.
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 safety mechanism failure was inconclusive because of the nature of the submitted evidence.The product returned for evaluation was two photographs which depicted a 20ga x 2.25¿ accucath ace peripheral iv catheter assembly.The catheter had been advanced and was not visible in the photographs.In both photographs, the guidewire appeared to be fully advanced.The guidewire exhibited curved shape memory.The needle was not withdrawn into the housing.No obvious device deficiency was observed during examination of the returned photographs.The needle was not withdrawn; however, it could not be determined if the safety button was pressed, nor could the safety mechanism be thoroughly inspected or tested.Consequently this complaint is inconclusive at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "needle would not safety." additional info.Received: accucath placed without difficulty, when button depressed to safety needle, it would not retract.Button was fully depressed.No patient harm.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20GX2.25
• Common Device Name: 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: 13599088
• Report Number: 3006260740-2022-00463
• Device Sequence Number: 14886148
• Product Code: FOZ
• UDI-Device Identifier: 00801741111006
• UDI-Public: (01)00801741111006
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: AC0202252
• Device Lot Number: REFU1390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown