MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "a broken picc in a patient.I am the supervisor and we had a picc break apart during removal.Half was left in the patient.We snared it out and have both pieces." no other information was provided.Additional information received 05/02/2024: it was reported, "s/l picc line placed in rt ij.Lot# rehu2613.Date of event was 04/29/24.No patient impact.".
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 break in the catheter is confirmed and was determined to be use-related.One 4 fr s/l powerpicc solo was returned for evaluation.An initial visual observation revealed use residues throughout the returned product.The catheter was broken just proximal to the 9 cm depth marker.A tactile evaluation of the catheter revealed tensile weakness in the distal fragment of the returned catheter.No significant tensile weakness was observed along the proximal fragment of the returned catheter.A microscopic observation revealed the proximal break site to have a granular fracture surface with some sections of the break having a sharp, uneven fracture surface.The proximal break site appeared to have a slight elliptical shape.Some material wear was observed along one area of the fracture edges.The distal break site appeared to have abundant blood use residues occluding the distal portion of the catheter.The distal break site appeared to have an elliptical shape with a granular fracture surface.Some material wear was observed along one area of the fracture edges of the distal break site.Based on the characteristics of the returned catheter break, the cause of failure appears to be a combination of flexural fatigue, or cyclic kinking of the catheter at the securement site, along with potentially tensile (pulling) forces applied to the catheter.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, "a broken picc in a patient.I am the supervisor and we had a picc break apart during removal.Half was left in the patient.We snared it out and have both pieces." no other information was provided.Additional information received (b)(6) 2024: it was reported, "s/l picc line placed in rt ij.Lot# rehu2613.Date of event was (b)(6) 2024.No patient impact.".

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN)
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19383899
• Report Number: 3006260740-2024-02584
• Device Sequence Number: 11780041
• Product Code: LJS
• UDI-Device Identifier: 00801741027765
• UDI-Public: (01)00801741027765
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/23/2024

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 Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 3194155
• Device Lot Number: REHU2613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: Required Intervention
• Patient Sex: Unknown