MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; 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	07/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regn4110 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "attempted to insert dilator sheath, had nick skin 3 times, still unable to advance, noted fracture in the peel way sheath, second sheath dropped and noted it was bent at the tip, two clinicians attempted to insert unsuccessfully, dropped a 4fr dilator sheath and was able to advance without issues." it was reported this occurred with two devices.This report addresses the first device.
Additional Manufacturer Narrative
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 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 was difficult to insert was confirmed but the cause is unknown.Four photographs of two damaged 3.5fr microez microintroducer/dilator/sheaths were returned for evaluation.The sheaths had not been split on either sample and the dilators were still found inlaid within the sheaths.The distal ends of the sheaths both contained deformation where the material appeared jagged and was slightly flared outward away from the dilator shaft.This damage can be indicative of a difficult placement.In addition to the damage on the distal end of the sheaths, one of the samples contained a bend in the introducer shaft.The sheath appeared to be buckled/ballooned in the bent region.It is likely that the difficult insertion contributed to the visible damage on the samples.However, it is not known if additional unknown factors contributed to this event.Microscopic observation, tactile evaluation, and dimensional analysis could not be conducted without the physical samples.Therefore, the exact root cause of the difficult insertion could not be determined.Possible contributing factors could include a steep insertion angle, advancement against resistance, a poor transition of the introducer sheath to the dilator, or damage to the sheath prior to use.Sheath damage can be minimized 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.
Event or Problem Description
It was reported by the customer "attempted to insert dilator sheath, had nick skin 3 times, still unable to advance, noted fracture in the peel way sheath, second sheath dropped and noted it was bent at the tip, two clinicians attempted to insert unsuccessfully, dropped a 4fr dilator sheath and was able to advance without issues." it was reported this occurred with two devices.This report addresses the first device.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• 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: 15136463
• Report Number: 3006260740-2022-02981
• Device Sequence Number: 5208632
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/24/2022

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: S4153108BDP
• Device Lot Number: REGN4110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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