MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F DL FT MAX BARRIER PLUS KIT; 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	02/23/2023
Type of Reportable Event	Malfunction
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.
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.  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.".
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 air aspiration when attempting to aspirate through the t-lock assembly luer was confirmed.The product returned for evaluation was one 5fr d/l powerpicc catheter.The sample was received with an inlaid stylet and attached t-lock assembly.The catheter appeared untrimmed.The wire had been partially withdrawn through the t-lock assembly.Microscopic inspection of the t-lock septum revealed gaps around the stylet wire.An attempt to infuse and aspirate water through the sample using a 12ml syringe revealed the sample to be patent to infusion without difficulty; however, during aspiration, air was withdrawn into the syringe.The air appeared to be aspirated through the t-lock septum.The complaint of air aspiration through the t-lock assembly was confirmed.The sample was evaluated and this event was determined to be related to a manufacture condition.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 h.11.
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.  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.".

• Brand Name: POWERPICC PROVENA 5F DL FT MAX BARRIER PLUS 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16616800
• Report Number: 3006260740-2023-00998
• Device Sequence Number: 17679559
• Product Code: LJS
• UDI-Device Identifier: 00801741154959
• UDI-Public: (01)00801741154959
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1275108FD3
• Device Lot Number: REGY0419
• 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: 05/26/2023
• Initial Report FDA Received Date: 03/26/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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