MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG(TPS) STYLET (4F) (SINGLE-LUMEN); 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	08/26/2023
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 by customer that 4 fr single lumen picc rupture at 40cm mark.Rupture found on line removal therapy no longer needed.No other information provided.Additional info from customer: ((b)(6) 2023) catheter was removed (b)(6) 2023 no new catheter placed as therapy complete.Patient mentioned to nurse removing the line that she had a lot of issues with it so rn closely inspected catheter and found rupture at 40 cm mark.It was secured with secur-a-cath.No pt harm reported.Was being treated for persistent headaches and double vision adjustment of programmable shunt.They do not have an infection disease.Unkown when catheter rupture occurred.
Additional Manufacturer Narrative
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.Based on a review of this information, the following was concluded: the complaint of a split is confirmed and was determined to be use related.One 4 fr s/l powerpicc was returned for evaluation.A functional test of attempting to infuse water distal of the observed 2 cm long split revealed a complete blood occlusion just distal of the split.A granular fracture surface was observed with tensile weakness around the split which suggested the split was due to a burst.The complaint of a split in a powerpicc is confirmed and was determined to be use related.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that 4 fr single lumen picc rupture at 40cm mark.Rupture found on line removal therapy no longer needed.No other information provided.Additional info from customer: ((b)(6) 2023) catheter was removed (b)(6) 2023 no new catheter placed as therapy complete.Patient mentioned to nurse removing the line that she had a lot of issues with it so rn closely inspected catheter and found rupture at 40 cm mark.It was secured with secur-a-cath.No pt harm reported.Was being treated for persistent headaches and double vision adjustment of programmable shunt.They do not have an infection disease.Unkown when catheter rupture occurred.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG(TPS) STYLET (4F) (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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17752916
• Report Number: 3006260740-2023-04118
• Device Sequence Number: 15145612
• Product Code: LJS
• UDI-Device Identifier: 00801741152566
• UDI-Public: (01)00801741152566
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000819
• Device Lot Number: REHN3223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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: Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 98 KG