MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER SHERLOCK 3CG (TPS) STYLET 5F BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that dl picc line with a leaking t lock assembly.Device was used on one patient.No harm reported.The event did not involve an urgent or life threatening situation.The leak was discovered when i was flushing the line during insertion, the event did not interrupt treatment and no signs, symptoms or complications experience by patient.We secured the device with a stat lock.There was no patient harm noted due to my intervention.".
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 device has not been returned to the manufacturer for evaluation.
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 leaking stopper was confirmed.The returned sample was found to exhibit the same features as a previously investigated event, and the root cause was found to be within the same scope.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that dl picc line with a leaking t lock assembly.Device was used on one patient.No harm reported.The event did not involve an urgent or life-threatening situation.The leak was discovered when i was flushing the line during insertion, the event did not interrupt treatment and no signs, symptoms or complications experience by patient.We secured the device with a stat lock.There was no patient harm noted due to my intervention.

• Brand Name: POWERPICC CATHETER SHERLOCK 3CG (TPS) STYLET 5F BASIC 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19281152
• Report Number: 3006260740-2024-02269
• Device Sequence Number: 6336224
• Product Code: LJS
• UDI-Device Identifier: 00801741034589
• UDI-Public: (01)00801741034589
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/27/2024

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: 1275118
• Device Lot Number: REHR1492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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 Sex: Unknown