MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER; 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	Swelling/ Edema (4577)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that they noted leaking at the insertion site.There was a picc lumen that a horizonal split at the 7cm mark.Picc placed on (b)(6) 24 by picc rn.Rn stated no issues with placement.Patient was discharged home on (b)(6) 24 with the picc line.Picc line was working at time of discharge.Patient came back into the ed on (b)(6) 24 due to his home health nurse being unable to obtain blood return from the picc lumen and reported difficulty flushing the line.The ed confirmed in the chart that upon arrival the picc lumen was not working properly.Cathflo was given in the ed and the nurse reported that the line flushed and drew blood.Patient was discharged home.Patient arrived to the ed on (b)(6) 24 due to the picc line leaking.Patient reported that he has been getting daily abx with no pain or difficulty flushing the line.However, patient reported that the home health nurses were stating "blood return difficulties".The vascular access team was consulted to the ed.When rn arrived, they noticed no leaking at the site when flushed.After re-dressing the line they noted leaking at the insertion site and also noted swelling around the insertion site that appeared to be infiltrated.The picc line was removed from the patients arm.The picc was flushed (outside of the patients arm) and they noted a horizontal split along the 7cm mark.On initial placement, charting showed 0cm left out.
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 evaluate.Results are expected soon.
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 catheter fracture was confirmed.The product returned for evaluation was one 4fr sl powerpicc solo catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed between the 6cm and 7cm depth markers.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: ¿ damage which was circumferentially aligned ¿ fracture edges which were rounded and polished due to repeated material wear ¿ 'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together ¿ overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing) an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The damage location suggested that catheter securement, access and maintenance techniques may have contributed.
Event or Problem Description
It was reported by customer that they noted leaking at the insertion site.There was a picc lumen that a horizonal split at the 7cm mark.Picc placed on (b)(6) 2024 by picc rn.Rn stated no issues with placement.Patient was discharged home on (b)(6) 2024 with the picc line.Picc line was working at time of discharge.Patient came back into the ed on (b)(6) 2024 due to his home health nurse being unable to obtain blood return from the picc lumen and reported difficulty flushing the line.The ed confirmed in the chart that upon arrival the picc lumen was not working properly.Cathflo was given in the ed and the nurse reported that the line flushed and drew blood.Patient was discharged home.Patient arrived to the ed on (b)(6) 2024 due to the picc line leaking.Patient reported that he has been getting daily abx with no pain or difficulty flushing the line.However, patient reported that the home health nurses were stating "blood return difficulties".The vascular access team was consulted to the ed.When rn arrived, they noticed no leaking at the site when flushed.After re-dressing the line they noted leaking at the insertion site and also noted swelling around the insertion site that appeared to be infiltrated.The picc line was removed from the patients arm.The picc was flushed (outside of the patients arm) and they noted a horizontal split along the 7cm mark.On initial placement, charting showed 0cm left out.

• Brand Name: POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER
• 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: 19281026
• Report Number: 3006260740-2024-02266
• Device Sequence Number: 20750426
• Product Code: LJS
• UDI-Device Identifier: 00801741154997
• UDI-Public: (01)00801741154997
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 1194108D3
• Device Lot Number: REHZ0407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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