MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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	11/08/2021
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 refs1622 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported by customer "when inserting the dilator the inner portion of the dilator (in between the white and gray) was stiff and rigid, causing it to catch on the skin that then caused bending of the dilator.This resulted in her having to drop an additional dilator onto the sterile filed.No harm was made to the patient." it was reported "this causes her to have to nick the skin to allow the dilator to go in, and many times this causes severe bleeding around insertion site.When severe bleeding occurs the customer reports major concerns for infection due to them having to redress the site 24 hours.".
Event or Problem Description
It was reported by customer "when inserting the dilator the inner portion of the dilator (in between the white and gray) was stiff and rigid, causing it to catch on the skin that then caused bending of the dilator.This resulted in her having to drop an additional dilator onto the sterile filed.No harm was made to the patient." it was reported "this causes her to have to nick the skin to allow the dilator to go in, and many times this causes severe bleeding around insertion site.When severe bleeding occurs the customer reports major concerns for infection due to them having to redress the site 24 hours.".
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 damaged microintroducer is confirmed but the exact cause remains unknown.One 5 fr microez microintroducer was returned for evaluation.One 5 fr microez microintroducer was returned for evaluation.The grey sheath was returned with the dilator and had not been split.Blood residue was visible within the device.The sheath and dilator were curved and bent.Microscopic observation of the sheath tip revealed two localized deformation points bunched inwards.Based on the damage observed, possible contributing factors include advancement against resistance.The product instructions for use (ifu) states, ¿advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.Verify institutional guidelines concerning the use of a scalpel prior to making incision.¿ since the sheath tip was observed to be damaged, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: 12913206
• Report Number: 3006260740-2021-05098
• Device Sequence Number: 5085264
• Product Code: LJS
• UDI-Device Identifier: 00801741154911
• UDI-Public: (01)00801741154911
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 01/26/2022

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: S1395108D2
• Device Lot Number: REFS1622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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