MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SOLO SP 3F SL; 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	06/04/2023
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that 3fr peel away sheath unable to thread through tissue despite no issue with inner dilator.Noted to have ridges on end of sheath.Used 3.5fr cook picc peel away.No problems with product.Remainder of procedure completed without incident.(b)(6)2023 additional information provided: it was reported by the customer "no prior medical history; diagnosis new cerebral mass.Picc needed for lab monitoring and chemotherapy.Event did not involve an urgent/life threatening situation.No negative outcome to patient.Procedure took longer to complete as two separate kits needed to be opened in order to get peel away sheath needed for procedure.".
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 complaint of difficult inserting the microintroducer is confirmed but the exact cause remains unknown.One 4.5 fr microez microintroducer and one non-bd 3.5 fr microintroducer were returned for evaluation.Blood residue and evidence of use was noted on the devices.Deformation was noted on the distal end of the grey sheath.Microscopic inspection of the deformed region revealed inward bunching of the sheath.Evidence of a sheath tip taper was observed.While the event could be confirmed based on the state of the observed sample, there was insufficient evidence to confirm the root cause of that event.
Event or Problem Description
It was reported by the customer that 3fr peel away sheath unable to thread through tissue despite no issue with inner dilator.Noted to have ridges on end of sheath.Used 3.5fr cook picc peel away.No problems with product.Remainder of procedure completed without incident.07/06/2023 additional information provided: it was reported by the customer "no prior medical history; diagnosis new cerebral mass.Picc needed for lab monitoring and chemotherapy.Event did not involve an urgent/life threatening situation.No negative outcome to patient.Procedure took longer to complete as two separate kits needed to be opened in order to get peel away sheath needed for procedure.".

• Brand Name: DOT PROV SOLO SP 3F SL
• 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 bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17313289
• Report Number: 3006260740-2023-02939
• Device Sequence Number: 15009176
• Product Code: LJS
• UDI-Device Identifier: 00801741134135
• UDI-Public: (01)00801741134135
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1193108PD
• Device Lot Number: REGZ0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: 6 YR
• Patient Sex: Female
• Patient Weight: 25 KG