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	Break (1069)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a peripherally inserted central catheter (picc) line placed on right basilic vein.The line site looked inflamed/irritated and antibiotics being administered through it were leaking.Order to remove the picc was obtained.The registered nurse (rn) noted upon removal the line was not intact, approximately 8" were retrieved.The end of the portion retrieved looked frayed.A chest x-ray (cxr) was taken and the rest of the picc line was found in the main and right pulmonary arteries.The patient was taken to interventional radiology where the retained portion was removed.The retained fragment measures approximately 14".Patient had no complications from the retention or removal of the retained fragment.
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 break in the catheter is confirmed and was determined to be related to use of the device.One 4 fr powerpicc solo was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned catheter.The catheter was observed to be broken between the 5 cm and 6 cm depth markers.The catheter was observed to have deformation from approximately the 3 cm depth marker to the 6 cm depth marker.A tactile evaluation of the returned powerpicc solo revealed some tensile weakness in the proximal end of the returned catheter.No significant tensile weakness was observed along the distal fragment of the returned catheter.A microscopic observation revealed the catheter to have discoloration from the 3 cm depth marker to the 6 cm depth marker.The break site appeared to fold over the catheter as the material appeared stretched.The catheter material between the 3 cm depth marker to the 6 cm depth marker appeared stretched.Small splits could be observed along the proximal break site appearing like a burst balloon.An occlusion was observed distal to the burst site, and this may have contributed to the failure.Forceful flushing against an occlusion can cause this type of failure.An examination of the catheter structure revealed no potential damage/defect related to the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported a peripherally inserted central catheter (picc) line placed on right basilic vein.The line site looked inflamed/irritated and antibiotics being administered through it were leaking.Order to remove the picc was obtained.The registered nurse (rn) noted upon removal the line was not intact, approximately 8" were retrieved.The end of the portion retrieved looked frayed.A chest x-ray (cxr) was taken and the rest of the picc line was found in the main and right pulmonary arteries.The patient was taken to interventional radiology where the retained portion was removed.The retained fragment measures approximately 14".Patient had no complications from the retention or removal of the retained fragment.

• 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: 19470934
• Report Number: 3006260740-2024-02809
• Device Sequence Number: 7423453
• Product Code: LJS
• UDI-Device Identifier: 00801741154997
• UDI-Public: (01)00801741154997
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 08/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1194108D3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 155 KG
• Patient Race: White