MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 4F SL W/GUARDIVA, 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 Codes	Erythema (1840); Infiltration into Tissue (1931); Swelling/ Edema (4577)
Date of Event	06/04/2024
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported that, "our patient had her picc line placed (b)(6), she came to the ed yesterday because she said she felt a pop when giving meds on prior evening.Long story short, i removed it (it was placed to the 0cm mark) and between the 6 and 7cm mark there is a hole/slit." no other information was provided.Additional information received 06/12/2024: "patient admitted to ed with complaints of pain around the picc site.Patient states that she felt a pop yesterday evening when she was flushing her picc and it scared her.Upon visual assessment, site appears within normal limits other than some various reddened areas that appear to be medical adhesive injury.Upon palpation of site, there is a slightly firm palpable edematous area approx 4cm above insertion site towards axilla area, not painful with palpation.At 1651, old dressing removed.Site cleansed per p&p and sterile dressing change completed without complications.After completing the dressing change, prn end cap changed and picc catheter flushed.Patient instantly stated having pain just above insertion site (previously noted edematous area) and the saline flush did not feel normal to the rn.The rn then used ultrasound to visualize the edematous area while flushing with saline and the site was infiltrating upon flush.At 1715, picc catheter removed with a total of 51cm removed.Petroleum dressing, gauze and tegaderm applied to site.Picc catheter was visually inspected and there is a hole/slit in catheter between the 6 and 7 cm marking.When catheter flushed with saline on bedside table, saline is noted leaking from same hole/slit noted between 6 & 7cm mark.Staff updated on situation.At 1745, us guided piv placed.Patient tolerated well with comfort measures and reassurance provided.There injury to the patient from infiltration.Picc line had to be removed, leaving the patient with no further long term options for vascular access placement in her arms consequently leading to having to be admitted to hospital and had to have a left ij subcutaneous implanted port placed.".
Event or Problem Description
It was reported that, "our patient had her picc line placed may 20th, she came to the ed yesterday because she said she felt a pop when giving meds on prior evening.Long story short, i removed it (it was placed to the 0cm mark) and between the 6 and 7cm mark there is a hole/slit." no other information was provided.Additional information received 06/12/2024: "patient admitted to ed with complaints of pain around the picc site.Patient states that she felt a pop yesterday evening when she was flushing her picc and it scared her.Upon visual assessment, site appears within normal limits other than some various reddened areas that appear to be medical adhesive injury.Upon palpation of site, there is a slightly firm palpable edematous area approx 4cm above insertion site towards axilla area, not painful with palpation.At 1651, old dressing removed.Site cleansed per p&p and sterile dressing change completed without complications.After completing the dressing change, prn end cap changed and picc catheter flushed.Patient instantly stated having pain just above insertion site (previously noted edematous area) and the saline flush did not feel normal to the rn.The rn then used ultrasound to visualize the edematous area while flushing with saline and the site was infiltrating upon flush.At 1715, picc catheter removed with a total of 51cm removed.Petroleum dressing, gauze and tegaderm applied to site.Picc catheter was visually inspected and there is a hole/slit in catheter between the 6 and 7 cm marking.When catheter flushed with saline on bedside table, saline is noted leaking from same hole/slit noted between 6 & 7cm mark.Staff updated on situation.At 1745, us guided piv placed.Patient tolerated well with comfort measures and reassurance provided.There is injury to the patient from infiltration.Picc line had to be removed, leaving the patient with no further long-term options for vascular access placement in her arms consequently leading to having to be admitted to hospital and had to have a left ij subcutaneous implanted port 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.The complaint of a leak is confirmed and was determined to be use related.One 4fr sl powerpicc solo catheter was returned for evaluation.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 6 and 7cm marks.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 ¿ 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.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO 4F SL W/GUARDIVA, 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19639833
• Report Number: 3006260740-2024-03364
• Device Sequence Number: 15594210
• Product Code: LJS
• UDI-Device Identifier: 00801741154997
• UDI-Public: (01)00801741154997
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 1194108D3
• Device Lot Number: REJN3821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 04/24/2025
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/19/2024; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MDS-24-5154-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female