MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER

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	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "microintroducer of 3fr provena midline kit buckled and failed during insertion." (b)(6) 2022- the dilator and sheath in the returned photo appeared to be bent near the distal end.The sheath material was buckled/ballooned directly proximal of the bent region on the microintroducer.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the microintroducer buckled was confirmed but the cause is unknown.A single photograph of the distal section of a microintroducer/dilator/sheath was returned for evaluation.Usage residue was seen on the device, indicating that the device had been used.The dilator and sheath appeared to be bent near the distal end.The sheath material was buckled/ballooned directly proximal of the bent region on the microintroducer.The bend in the microintroducer may indicate a difficult placement.However, it is unknown if additional unknown factors contributed to this event.Examination of the distal end of the device, microscopic observation, tactile evaluation, and dimensional analysis could not be conducted without the physical sample.Therefore, the exact root cause of the damage to the sheath could not be determined.Possible contributing factors could include too small of an incision, a steep insertion angle, a poor transition of the introducer sheath to the dilator, or damage to the sheath prior to use.The ifu states ¿avoid sheath damage by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.¿ if necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.A lot history review (lhr) of refy3780 showed no other similar product complaint(s) from this lot number.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14397579
• Report Number: 3006260740-2022-01775
• Device Sequence Number: 5563897
• Product Code: PND
• UDI-Device Identifier: 00801741153969
• UDI-Public: (01)00801741153969
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• 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
• Report Date (Section B): 04/28/2022

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: S4153108D
• Device Lot Number: REFY3780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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 Sex: Unknown