MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH; 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	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regq2381 showed two other similar product complaint(s) from this batch number.
Event or Problem Description
It was reported by the customer "peeling of introducer upon insertion.Opened second kit and was able to place introducer without difficulty." (b)(6) 2023.Additional information provided: no patient harm reported.
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 available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of the introducer peeling upon insertion is confirmed and was determined to be due to an unknown cause.One 3.5 fr microintroducer was returned for evaluation.An initial visual observation showed blood use residues throughout the microintroducer.There were no obvious sharp bends observed on the returned device, but the distal tip of the gray sheath appeared deformed.A microscopic observation revealed the entire distal tip of the gray sheath to be deformed and pushed towards the proximal end of the microintroducer.Nothing remarkable was observed throughout the rest of the complainant device.The complaint of peeling the microintroducer upon insertion of the device is confirmed.Due to the extent of the deformation, a cause cannot be established as the microintroducer had abundant use residues and deformation to the distal tip of the gray sheath.Possible causes may be angle of insertion of the device or a sharper taper angle due to the manufacturing process of the device.
Event or Problem Description
It was reported by the customer "peeling of introducer upon insertion.Opened second kit and was able to place introducer without difficulty." 01/24/2023 additional information provided: no patient harm reported.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16275056
• Report Number: 3006260740-2023-00292
• Device Sequence Number: 14707467
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/12/2023

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: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S4153108BDP
• Device Lot Number: REGQ2381
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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 Age: 31 YR
• Patient Sex: Female
• Patient Weight: 69 KG