MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH, 22 GX1.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
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 reew2013 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the active safety button did not allow the stylet needle to retract and the nitinol stayed partially coil while inside the patient¿s hand vein.' 'able to safely remove the catheter and wire intact without causing damage to the patient.".
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 guidewire being caught within the catheter was confirmed.The product returned for evaluation was one 22ga x1.25¿ accucath ace peripheral iv catheter assembly.Usage residues were observed throughout the sample.The safety button was depressed and the needle was fully withdrawn into the housing.The catheter was caught on the guidewire.Both the guidewire and catheter exhibited curved shape memory.Following removal of the catheter, the guidewire was observed to be intact.Microscopic inspection of the guidewire revealed the coils to be misaligned.Microscopic inspection of the catheter tip revealed slight deformation and discoloration.The curved shape memory, coil misalignment and catheter tip deformation were consistent with attempted insertion against resistance, such as into tissue.Such deformation likely resulted in the reported event of difficult safety activation/device placement.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "the active safety button did not allow the stylet needle to retract and the nitinol stayed partially coil while inside the patient¿s hand vein.' 'able to safely remove the catheter and wire intact without causing damage to the patient.".

• Brand Name: ACCUCATH, 22 GX1.25
• 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
• MDR Report Key: 11529398
• Report Number: 3006260740-2021-00882
• Device Sequence Number: 3791312
• Product Code: FOZ
• UDI-Device Identifier: 00801741110924
• UDI-Public: (01)00801741110924
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2021

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: AC0221250
• Device Lot Number: REEW2013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/04/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other