MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER, BELDAR NG); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
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 device has not been returned to the manufacturer for evaluation.Device not returned.
Event or Problem Description
It was reported that 4fr provena picc clamp on purple lumen cracked causing clamp not to fasten.Add info received (b)(6) 2023.Event did not involve urgent/life threatening event the crack was discovered when the nurse tried to clamp the clamp multiple times and it kept coming open.When she looked at it, she noticed the crack.The event caused the patient to have an over the wire exchange of the picc.No delay in care.No signs, symptoms or complications to patient.Stat lock securement was used.No leakage of medication/fluid because the crack in the clamp was noticed immediately after line was placed.
Event or Problem Description
It was reported that 4fr provena picc clamp on purple lumen cracked causing clamp not to fasten.Add info received 17-jul-2023 event did not involve urgent/life threatening event the crack was discovered when the nurse tried to clamp the clamp multiple times and it kept coming open.When she looked at it, she noticed the crack.The event caused the patient to have an over the wire exchange of the picc.No delay in care.No signs, symptoms or complications to patient.Stat lock securement was used.No leakage of medication/fluid because the crack in the clamp was noticed immediately after line was placed.
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged clamp was confirmed; however, the root cause was not identified.The product returned for evaluation was one 4fr dual lumen powerpicc provena catheter.Usage residues were observed throughout the sample.A fracture was observed in the purple-luered lumen clamp.Microscopic inspection of the fracture site revealed a granular fracture surface.No deformation was observed in the vicinity of the fracture.Slight discoloration was observed.Attempts to replicate the observed damage by manipulating the clamp of a non-complainant device resulted in abundant deformation and discoloration.The fracture features were consistent with brittle material failure.Attempts to replicate the fracture features were unsuccessful, suggesting that an additional unidentified environmental factor(s) likely affected the material properties of the clamp.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h11.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER, BELDAR NG)
• 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: 17424860
• Report Number: 3006260740-2023-03244
• Device Sequence Number: 15383905
• Product Code: LJS
• UDI-Device Identifier: 00801741155154
• UDI-Public: (01)00801741155154
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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 Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D5
• Device Lot Number: REHN3194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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