MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROVPPSOLO 4FDL MBP; 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	10/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refr1447 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refr1447) have been reported from the same facility.
Event or Problem Description
It was reported a 4fr sl picc kinked just within the insertion site.Add info rcvd (b)(6) 2021: kinked at 7.5 cm discovered via xray when unable to flush or aspirate picc.Was there patient harm reported?: some discomfort in arm.Placement date (b)(6) 2021.Placement info: placed in pt on 5g 17 (renal unit).What type of catheter securement was utilized: bard statlock.
Event or Problem Description
It was reported a 4fr sl picc kinked just within the insertion site.Add info rcvd (b)(6) 2022: kinked at 7.5 cm discovered via xray when unable to flush or aspirate picc was there patient harm reported?: some discomfort in arm placement date (b)(6) 2021.Placement info: placed in pt on 5g 17 (renal unit).What type of catheter securement was utilized: bard statlock.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked catheter was confirmed.The product returned for evaluation was one 4fr d/l provena powerpicc solo catheter.Usage residues were observed throughout the sample.A permanent kink impression was observed between the 7cm and 8cm depth markings.The sample kinked preferentially at the site of the kink impression during manual manipulation.Microscopic inspection of the sample revealed material wear and discoloration in the vicinity of the kink site.The kink impression and preferential kinking were consistent with sharp bending of the catheter shaft.The location of the kink suggested that catheter insertion or securement technique may have contributed.

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12836350
• Report Number: 3006260740-2021-04883
• Device Sequence Number: 4950254
• Product Code: LJS
• UDI-Device Identifier: 00801741154997
• UDI-Public: (01)00801741154997
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: S1294108D4
• Device Lot Number: REFR1447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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 Age: 64 YR
• Patient Sex: Female