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

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refs1506 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "accucath ace wire knotted up during insertion, was difficult to remove from patient." no other information was provided.

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 accucath guidewire damage was confirmed.The product returned for evaluation was one 20ga x 2.25¿ accucath ace peripheral iv catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned for evaluation.The safety button was depressed and the needle was fully withdrawn in to the housing.The guidewire exhibited deformation within the coil region.The wire appeared to be intact.Microscopic inspection of the guidewire confirmed it to be intact.A sharp kink was observed within the coil region, leading to misaligned coils.Blood residue was evident on the guidewire and the needle.The guidewire deformation was consistent with damage caused by attempted advancement against resistance, such as into tissue.The use residues suggested that advancement against resistance occurred during device use.H3 other text: evaluation findings are in section h11.

Event Description

It was reported "accucath ace wire knotted up during insertion, was difficult to remove from patient." no other information was provided.

• Brand Name: ACCUCATH, ACE 20GX2.25
• Type of Device: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12839875
• MDR Text Key: 281028958
• Report Number: 3006260740-2021-04942
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741137952
• UDI-Public: (01)00801741137952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AC1202250
• Device Lot Number: REFS1506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other