MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25; 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	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the needle failing to fully retract into the housing was confirmed; however, the root cause was not identified.The product returned for evaluation was three photographs depicting an accucaph peripheral iv catheter assembly.The catheter had been advanced and was not visible in the photographs.The safety button appeared to have been pressed and the needle was partially withdrawn into the housing.In the first photograph, the guidewire was fully withdrawn.In the second photograph, the guidewire was partially advanced, suggesting that the guidewire was mobile within the needle shaft.The distal end of the spring appeared to be dislocated from the distal end of the housing.The spring was bunched within the housing.The needle was confirmed to be only partially withdrawn into the housing; however, inspection of the photographs was insufficient to identify the cause of that failure.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.The safety mechanism failure may have related to a possible issue with the spring/housing.A lot history review (lhr) of refs3041 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "accucath failed to retract.Clinician discarded the product because it had been used on a patient.He had no way to secure to needle without potentially risking someone being stuck.".
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 the needle failing to fully retract into the housing was confirmed; however, the root cause was not identified.The product returned for evaluation was three photographs depicting an accucath peripheral iv catheter assembly.The catheter had been advanced and was not visible in the photographs.The safety button appeared to have been pressed and the needle was partially withdrawn into the housing.In the first photograph, the guidewire was fully withdrawn.In the second photograph, the guidewire was partially advanced, suggesting that the guidewire was mobile within the needle shaft.The distal end of the spring appeared to be dislocated from the distal end of the housing.The spring was bunched within the housing.The needle was confirmed to be only partially withdrawn into the housing; however, inspection of the photographs was insufficient to identify the cause of that failure.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.The safety mechanism failure may have related to a possible issue with the spring/housing.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "accucath failed to retract.Clinician discarded the product because it had been used on a patient.He had no way to secure to needle without potentially risking someone being stuck.".

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• 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: 12635607
• Report Number: 3006260740-2021-04390
• Device Sequence Number: 13803528
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/23/2021

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: AC0202250
• Device Lot Number: REFS3041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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