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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refp2302 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire got hung up on the catheter and kinked.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulties placing an accucath ace device is confirmed.One 22 g accucath ace needle housing and one 18 g accucath catheter were returned for evaluation.An initial visual observation showed use residue on the returned samples.The safety mechanism of the needle housing was observed to have been activated and the guidewire was observed to be looped with the tip stuck within the housing.A microscopic observation revealed the guidewire was protruding from the flash notch and the coiled tip of the guidewire was observed to be stuck within the flash notch.Once removed from the flash notch, it was found that the entire tip of the guidewire was present and intact.The position of the guidewire in the flash notch, which would make insertion and placement of the catheter difficult, was most likely caused by advancement of the guidewire against resistance which caused the guidewire to buckle.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that the guidewire got hung up on the catheter and kinked.

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER (22G)
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12697898
• Report Number: 3006260740-2021-04545
• Device Sequence Number: 1389350
• Product Code: FOZ
• UDI-Device Identifier: 00801741137990
• UDI-Public: (01)00801741137990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• 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): 12/29/2021

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: AC1221252
• Device Lot Number: REFP2302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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: 6 YR
• Patient Sex: Male
• Patient Weight: 34 KG