MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SOLO SP 4F DL; 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	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "dr.Has identified quality issues with our bard powerpicc provena lines.There is no specific differentiation for what piccs we are seeing the issue with (single vs dual, 3-5fr), wire pulls out smoothly, but then noted to have be bent to the point of nearly breaking.Risk is of dislodgment in the line/vessel".
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regq1413 showed no other similar product complaint(s) from this lot number.
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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked stylet was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a 3cg tls stylet.The depicted region of the device included most of the plastic-coated region.The device was held by a gloved hand and use residues were observed on the glove and stylet.The stylet appeared to be intact; however, a kink was observed near the distal epoxy.The plastic coating appeared deformed and narrowed within he kinked region.Stylet damage was observed in the submitted photograph; however, inspection of the photograph was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as cause unknown¿ at this time.Potential contributing factors include complete removal and re-insertion of the stylet during catheter trimming, insertion of the stylet past the tip of the trimmed catheter, and stylet manipulation prior to or during attempted use.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported that "wire pulls out smoothly, but then noted to have be bent to the point of nearly breaking.Risk is of dislodgment in the line/vessel".Additional information: sedation team was placing a 4fr powerpicc provena dual lumen catheter, when the doctor noticed the guidewire, or positioning wire was bent.The wire pulled out smoothly, but then under further investigation, it was noted to have been bent to the point of nearly breaking.Patient is being treated for neuroblastoma with chemotherapy.
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 a kinked stylet is confirmed; however, the root cause could not be determined.The products returned for evaluation were five 4fr dual lumen powerpicc provena kits.All five kits were received in their original sealed packages.The packages were unremarkable.The kits were opened and the included guidewires, catheters and inlaid stylets were inspected.The components appeared unremarkable.The lengths of the magnet strings were measured in all three stylet and found to be within manufacturing specifications per (b)(4).Also received was one photograph which showed a 3cg tls stylet.The depicted region of the device included most of the plastic-coated region.The device was held by a gloved hand and use residues were observed on the glove and stylet.The stylet appeared to be intact; however, a kink was observed near the distal epoxy.The plastic coating appeared deformed and narrowed within he kinked region.Stylet damage was observed in the submitted photograph; however, inspection of the photograph was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings in section h:11.
Event or Problem Description
It was reported that "wire pulls out smoothly, but then noted to have be bent to the point of nearly breaking.Risk is of dislodgment in the line/vessel" additional information: sedation team was placing a 4fr powerpicc provena dual lumen catheter, when the doctor noticed the guidewire, or positioning wire was bent.The wire pulled out smoothly, but then under further investigation, it was noted to have been bent to the point of nearly breaking.Patient is being treated for neuroblastoma with chemotherapy.

• Brand Name: DOT PROV SOLO SP 4F DL
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15735429
• Report Number: 3006260740-2022-04277
• Device Sequence Number: 17721375
• Product Code: LJS
• UDI-Device Identifier: 00801741134197
• UDI-Public: (01)00801741134197
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162441
• 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,Followup
• Report Date (Section B): 04/25/2024

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: S1294108PD
• Device Lot Number: REGQ1413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 01/25/2023; 04/25/2024
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/31/2023; 05/07/2024
• 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: 24 MO
• Patient Sex: Male
• Patient Weight: 12 KG