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

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 06/15/2023

Event Type  malfunction  

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.

Event 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.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 second sample.

• Brand Name: PROVEN A TM MIDLINE CATHETER 3F SL
• Type of Device: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18311960
• MDR Text Key: 330951189
• Report Number: 3006260740-2023-05649
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741187827
• UDI-Public: (01)00801741187827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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