MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER; 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	02/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, "regarding picc insertion kits that recently have transitioned to newer style kits with a different extension set with the wire extending through the port.The new style t-port has a more concave style in which the wire feeds through.  the insertion of single lumen lot regx3255 air entered the catheter at the t-port into the picc and pulled back air as they retracted the t-port syringe.The picc was immediately removed or clamped and managed without patient harm.The sl picc was aborted, and a new kit used to place the line.".
Additional Manufacturer Narrative
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a leaking t-lock assembly was confirmed and the cause was related to device manufacture.The product returned for evaluation was one 4fr s/l powerpicc catheter.The sample was received with an inlaid stylet and attached t-lock assembly.Tactile comparison between the complaint sample and a non-complainant device revealed that the complaint sample wire was easier to manipulate within the t-lock septum.An attempt to infuse water through t-lock using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed in the septum where the wire passed through.Microscopic inspection of the septum revealed gaps on two sides where the wire passed through an incision.Leaking water was observed at those gaps.The gaps at the wire insertion site resulted in the observed leakage and occurred during as a result of the manufacturing process.Bd is working to prevent future occurrences of similar events and values your support and partnership in communicating this event and coordinating the sample return.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer, "regarding picc insertion kits that recently have transitioned to newer style kits with a different extension set with the wire extending through the port.The new style t-port has a more concave style in which the wire feeds through.  the insertion of single lumen lot regx3255 air entered the catheter at the t-port into the picc and pulled back air as they retracted the t-port syringe.The picc was immediately removed or clamped and managed without patient harm.The sl picc was aborted, and a new kit used to place the line.".

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER
• 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: 16613901
• Report Number: 3006260740-2023-00988
• Device Sequence Number: 4817633
• Product Code: LJS
• UDI-Device Identifier: 00801741154935
• UDI-Public: (01)00801741154935
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• 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): 05/19/2023

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 1174108D3
• Device Lot Number: REGX3255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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