MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 4 FR POWERPICC CATHETER PLACEMENT KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received by the manufacturer for evaluation.
Event or Problem Description
It was reported nurse inserted introducer for picc placement and the safety would not activate on the introducer.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 safety mechanism that did not activate was confirmed but the root cause could not be determined.The product returned for evaluation was one 21g b.Braun safecan introducer needle.A gross visual inspection of the returned unit found that the safecan component was not returned.The metal clip was still present and found near the proximal end of the needle.The metal clip was functionally tested by attempting to slide the clip down the needle and over the needle tip.The metal clip moved without resistance and adequately covered the needle tip.However, without the safecan component the metal clip could easily be dislodged from the needle tip.Because the device was returned opened and used without the safecan, the complaint of a safety mechanism not activating correctly is confirmed but the exact cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported nurse inserted introducer for picc placement and the safety would not activate on the introducer.No other information was provided.

• Brand Name: 4 FR POWERPICC CATHETER PLACEMENT KIT
• 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: 20433257
• Report Number: 3006260740-2024-05876
• Device Sequence Number: 12659867
• Product Code: LJS
• UDI-Device Identifier: 00801741216008
• UDI-Public: (01)00801741216008(11)240506(17)250731(10)REJQ0825
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/11/2025

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 Expiration Date: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000986
• Device Lot Number: REJQ0825
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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