MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER 4F RADIOLOGY (DL) (W/ HYDRO-GLIDE INSERTION STYLET); 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	Skin Inflammation/ Irritation (4545)
Date of Event	10/30/2024
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
It was reported patient began having leaking of clear fluid from sternum on sunday night per report.Dressings were needing to be changed q2-6 hours because they were becoming saturated.It was thought to potentially be peritoneal fluid coming up through the diaphragm per cvs, and bedside was told by staff md to elevate patient to see if gravity assisted in decreasing the amount of drainage.It was also speculated by md whether or not it was jp fluid and to strip the chest tubes really well.A pico dressing was applied by cvs on tuesday nov 5 at approx 1400.By 1600 there was an area of drainage the approximate size of a toonie.By 1900 50% of the pico dressing was saturated.By the time i came back the next morning the dressing was fully saturated and had been leaking out of dressing and soaking the patient's bed.On rounds said i was concerned about the status of the patient's ra line because the fluid coming out from the sternal wound was clear, not yellow like pd fluid, or serosang like jp fluid, and the sternal wound was otherwise intact.All medications were moved from the ra line to the picc line.Cvl chasers were run at the minimum rate required to keep the ra line from clotting.The pico was removed and a dry gauze was applied to the sternum to monitor output.The weight of the pico dressing was 86g and the estimated med delivery volume into that line would have been approx 122 ml since the pico was applied.Throughout the day, with the reduced volume running through the line, the sternal dressing remained clean and dry.The decision was made to remove the ra line, and upon removal by cvs, the catheter of the line was noted to have a large crack post insertion site.The patient was running high k, ca gluconate, milrinone, and dexmedetomidine in that line.The patient's skin was found to be ++ red and irritated/rashy by the end of the shift.It was cleaned thoroughly with soap and water.No other information was provided.
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 split in the catheter was confirmed.The product returned for evaluation was one 4 fr d/l powerpicc sv catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue may occur 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 just distal of the 0 cm depth marker.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).Repetitive kinking of the indwelling catheter appears to have contributed to the observed leak; however, the specific circumstances surrounding how kinking developed into a fracture within the catheter tubing were ultimately unknown.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.Environmental factors may have contributed to the fracture propagation on either side of the circumferential split.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported patient began having leaking of clear fluid from sternum on sunday night per report.Dressings were needing to be changed q2-6 hours because they were becoming saturated.It was thought to potentially be peritoneal fluid coming up through the diaphragm per cvs, and bedside was told by staff md to elevate patient to see if gravity assisted in decreasing the amount of drainage.It was also speculated by md whether or not it was jp fluid and to strip the chest tubes really well.A pico dressing was applied by cvs on tuesday nov 5 at approx 1400.By 1600, there was an area of drainage the approximate size of a toonie.By 1900, 50% of the pico dressing was saturated.By the time i came back the next morning the dressing was fully saturated and had been leaking out of dressing and soaking the patient's bed.On rounds said i was concerned about the status of the patient's ra line because the fluid coming out from the sternal wound was clear, not yellow like pd fluid, or serosang like jp fluid, and the sternal wound was otherwise intact.All medications were moved from the ra line to the picc line.Cvl chasers were run at the minimum rate required to keep the ra line from clotting.The pico was removed and a dry gauze was applied to the sternum to monitor output.The weight of the pico dressing was 86g and the estimated med delivery volume into that line would have been approx 122ml since the pico was applied.Throughout the day, with the reduced volume running through the line, the sternal dressing remained clean and dry.The decision was made to remove the ra line, and upon removal by cvs, the catheter of the line was noted to have a large crack post insertion site.The patient was running high k, ca gluconate, milrinone, and dexmedetomidine in that line.The patient's skin was found to be ++ red and irritated/rashy by the end of the shift.It was cleaned thoroughly with soap and water.No other information was provided.

• Brand Name: POWERPICC SV CATHETER 4F RADIOLOGY (DL) (W/ HYDRO-GLIDE INSERTION STYLET)
• 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: 20899377
• Report Number: 3006260740-2024-07353
• Device Sequence Number: 21084125
• Product Code: LJS
• UDI-Device Identifier: 00801741027864
• UDI-Public: (01)00801741027864(11)240628(17)270930(10)REJS2003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102159
• 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): 03/17/2025

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 Model Number: N/A
• Device Catalogue Number: 3274355
• Device Lot Number: REJS2003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown