MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 4F SL W/BIOPATCH, PROBE COVER, & BELDAR NEEDLE GUIDES; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
Received a call med center picc nurse stating, picc was placed on (b)(6)2024 by picc rn.Patient was discharged home on (b)(6) with picc in place.Patient was receiving home abx and dressing changes.Patient returned back to the facility on (b)(6)2024 with reported issues with picc.Rn assessed the line at that time and reported cathflo was given and that the picc was positional at times but working.This was reported a few other times and cathflo was given by outpatient infusion.Patient received the last abx treatment on (b)(6) but was instructed to keep picc in until (b)(6).Patient came into the outpatient infusion center and rn was called about the picc leaking.Nurse assessed the site and noted leaking.Picc was removed and at the 10.5cm mark a hole was noted.Prior xray was done before the removal of the picc and it was reported by the account that there was a kinked noted on the picc per xray imaging around the 10cm mark.External cm reported was 7cm.Securement used was securacath.No impact was reported.
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 damaged catheter is confirmed; however, the exact cause is unknown.Two photographs of a powerpicc were returned for evaluation.An initial visual observation of the photograph showed a circumferential split in the catheter tubing.A small amount of use residue was observed on the device in the returned photograph.No other damage to the catheter could be discerned from the returned photographs.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, received a call med center picc nurse stating, picc was placed on (b)(6) 2024 by picc rn.Patient was discharged home on (b)(6) with picc in place.Patient was receiving home abx and dressing changes.Patient returned back to the facility on (b)(6) 2024 with reported issues with picc.Rn assessed the line at that time and reported cathflo was given and that the picc was positional at times but working.This was reported a few other times and cathflo was given by outpatient infusion.Patient received the last abx treatment on (b)(6) but was instructed to keep picc in until (b)(6).Patient came into the outpatient infusion center and rn was called about the picc leaking.Nurse assessed the site and noted leaking.Picc was removed and at the 10.5 cm mark a hole was noted.Prior xray was done before the removal of the picc and it was reported by the account that there was a kinked noted on the picc per xray imaging around the 10 cm mark.External cm reported was 7 cm.Securement used was securacath.No impact was reported.

• Brand Name: POWERPICC SOLO 4F SL W/BIOPATCH, PROBE COVER, & BELDAR NEEDLE GUIDES
• 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: 20092934
• Report Number: 3006260740-2024-04822
• Device Sequence Number: 12703811
• Product Code: LJS
• UDI-Device Identifier: 00801741155192
• UDI-Public: (01)00801741155192
• 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
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 1194108D5
• Device Lot Number: REHX2405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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