MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PROVEN A TM MIDLINE CATHETER 3F SL

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	06/15/2023
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that 3fr dilators are buckling when trying to transition through skin.Additional information 6/19: in inability to advance dilator and sheath through skin required additional skin nick and obtaining new 3 fr.Dilator.No urgent/life threating medical situation.
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.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer sheath was confirmed; however, the root cause could not be determined.Two 3.5fr microintroducers were returned for evaluation.The leading edge of each microintroducer was damaged and plastically deformed.One sheath was buckled 1.3cm from the sheath tip.Due to the evidence of use, complications during the insertion process may have resulted in sheath damage; however, the root cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by customer that 3fr dilators are buckling when trying to transition through skin.Additional information 6/19, in inability to advance dilator and sheath through skin required additional skin nick and obtaining new 3 fr.Dilator.No urgent/life threating medical situation.On 12/08/2023 - two samples were returned for investigation.The leading edge of each microintroducer was damaged and plastically deformed on both samples.This report addresses the first sample.

• Brand Name: PROVEN A TM MIDLINE CATHETER 3F SL
• Common Device Name: MIDLINE CATHETER
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17239833
• Report Number: 3006260740-2023-02730
• Device Sequence Number: 5259901
• Product Code: PND
• UDI-Device Identifier: 00801741187827
• UDI-Public: (01)00801741187827
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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 Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000917
• Device Lot Number: REGW0792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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