MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER WITH SHERLOCK 3CG TPS STYLET 3F, 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	05/29/2024
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 evaluate.Results are expected soon.
Event or Problem Description
It was reported patient arrived to emergency department complaining of picc line leaking; dressing taken down & line flushed.Leaking noted at the junction of the extension tubing and lumen.Indentation from clamp noted.Possible overuse of clamp at location disrupted tubing integrity.Nothing was infusing at time of leak discovery.Inserted ac, secured with statlock.Picc d/c'd.Piv established to bridge, picc scheduled to be replaced 5/30.No patient harm.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 leak is confirmed; however, the exact cause is unknown.One photograph of a single lumen powerpicc sv was returned for evaluation.An initial visual observation of the photograph showed a drop of a clear liquid at the junction of the extension leg and the luer hub of the catheter.Use residue was observed on the sample in the returned photograph.While a drop of clear liquid could be seen on the catheter in the returned photograph, no damage was observed and there were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported patient arrived to emergency department complaining of picc line leaking; dressing taken down & line flushed.Leaking noted at the junction of the extension tubing and lumen.Indentation from clamp noted.Possible overuse of clamp at location disrupted tubing integrity.Nothing was infusing at time of leak discovery.Inserted ac, secured with statlock.Picc d/c'd.Piv established to bridge, picc scheduled to be replaced 5/30.No patient harm.No other information was provided.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TPS STYLET 3F, 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: 19630638
• Report Number: 3006260740-2024-03313
• Device Sequence Number: 20606291
• Product Code: LJS
• UDI-Device Identifier: 00801741152580
• UDI-Public: (01)00801741152580(11)230613(17)240731(10)REHR1555
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000821
• Device Lot Number: REHR1555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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: 15 MO
• Patient Sex: Female
• Patient Weight: 9 KG