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	07/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the introducers too easily buckling and becoming bent or the grey peel-a-way end begins to curl back on itself preventing the introducer from entering the vein wall.We were able to easily insert the introducer through the skin over the guide wire for about 1 inch after making a skin nick.However, when we tried to advance the introducer through the vein, we met resistance.When we tried to advance the introducer through the vein, we met resistance.We made a larger nick but had the same outcome.When we removed the introducer i could see and feel the gray edge had rolled back on itself.We had to open an additional midline kit to retrieve another introducer.When we retrieved a new introducer, it advanced easily like it's supposed to.".
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regq0632 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the introducers too easily buckling and becoming bent or the grey peel-a-way end begins to curl back on itself preventing the introducer from entering the vein wall.We were able to easily insert the introducer through the skin over the guide wire for about 1 inch after making a skin nick.However, when we tried to advance the introducer through the vein, we met resistance.When we tried to advance the introducer through the vein, we met resistance.We made a larger nick but had the same outcome.When we removed the introducer i could see and feel the gray edge had rolled back on itself.We had to open an additional midline kit to retrieve another introducer.When we retrieved a new introducer, it advanced easily like it's supposed to.".
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a difficult insertion is confirmed.One 3.5 fr x 7cm microez microintroducer was returned for evaluation.The written note indicated lot: regq0632.The dilator was returned, and the sheath had not been peeled.The sheath was observed to be bent at the proximal end extending from the peelable tabs and in the center region of the sheath tubing.Bunching of the sheath tip was also noted.Microscopic observation of the sheath tip revealed the material to be compressed and bunched inwards.The sheath tip taper transition did not appear to be smooth.It was flat which created a blunt surface.Since the condition of the sheath tip taper likely contributed to the insertion of the device, the complaint is confirmed.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.

• 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: 15204333
• Report Number: 3006260740-2022-03131
• Device Sequence Number: 11912603
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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 Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: S4153108BDP
• Device Lot Number: REGQ0632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/31/2022
• 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 Sex: Unknown