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	11/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "accucath needle would not retract when safety activated post guidewire deployment.Needle manually removed from catheter once inserted into patient, and retracted into safety casing used gravity.".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw1505 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "accucath needle would not retract when safety activated post guidewire deployment.Needle manually removed from catheter once inserted into patient, and retracted into safety casing used gravity.".
Event or Problem Description
It was reported "accucath needle would not retract when safety activated post guidewire deployment.Needle manually removed from catheter once inserted into patient, and retracted into safety casing used gravity.".
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 confirmed and the cause appeared to be manufacturing related.The product returned for evaluation was one 20ga x 2.25¿ accucath peripheral iv catheter assembly.Light usage residues were observed.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catheter had been advanced and was not returned for evaluation.The safety button was depressed and the needle was fully withdrawn into the housing.The spring was compressed and attached to the needle carrier.Microscopic inspection of the device confirmed that the spring was compressed and attached to the needle carrier.The needle was exposed by gently shaking the housing while held upside down.The lack of spring engagement with the top of the needle housing prevented the safety from functioning as intended.The spring appeared to be adhered to the needle carrier, which likely occurred during device assembly.Photographs have been forwarded to the manufacturing site for further evaluation.

• 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: 12910452
• Report Number: 3006260740-2021-05085
• Device Sequence Number: 14723803
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 03/23/2022

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: AC0202250
• Device Lot Number: REFW1505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 03/23/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/17/2021; 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 63 KG