MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER W/ SHERLOCK 3CG (TPS) STYLET FULL TRAY; 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that piccs are leaking.Had to clean up mess and replace.No other information was provided.A specific number of affected devices or patients was no provided by the complainant.
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 leaking catheters is confirmed and was determined to be use-related.Three 4 fr d/l powerpicc sv catheters were returned for evaluation.An initial visual observation revealed abundant use residues throughout each of the three returned catheters.A small split was observed along sample 1, sample 2 and sample 3 each along the catheter tubing just distal of the molded suture wing.A microscopic observation revealed the split located just distal of the molded suture joint for sample 1 was circumferentially aligned with rounded, polished edges and ¿c¿ shaped impressions leading into the split.The split located just distal of the molded suture joint for sample 2 was circumferentially aligned with rounded, polished edges.The split located just distal of the molded suture joint for sample 3 was circumferentially aligned with rounded, polished edges and ¿c¿ shaped impressions leading into the split.The characteristics observed in each split of each of the returned devices coincide with the features typical of flexural fatigue, or cyclic kinking of the catheter tubing causing the material to wear.Based on the microscopic observations of the splits found in each of the three samples returned for evaluation, the complaint of a leaking catheter is confirmed and was determined to be due to flexural fatigue.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by customer that piccs are leaking.Had to clean up mess and replace.No other information was provided.(b)(6) 2024 - three devices were returned for evaluation.This report addresses the first device.

• Brand Name: POWERPICC SV CATHETER W/ SHERLOCK 3CG (TPS) STYLET FULL TRAY
• 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: 17494668
• Report Number: 3006260740-2023-03434
• Device Sequence Number: 7821883
• Product Code: LJS
• UDI-Device Identifier: 00801741086908
• UDI-Public: (01)00801741086908
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 01/31/2024

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 Model Number: N/A
• Device Catalogue Number: 1274108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 02/15/2024
• 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: Other
• Patient Sex: Unknown