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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that during dual lumen picc procedure, the port with the stylet was having resistance when flushing, and then started leaking from the green luer lock side port between the green hub and the clear plastic tubing.Appears to have a narrowing of the tubing within the connection of the hub and clear tubing.No patient harm or impact.Picc inserter noticed leak before insertion so new picc kit was opened, and no leakage or defect was noted from the second kit.
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that during dual lumen picc procedure, the port with the stylet was having resistance when flushing, and then started leaking from the green luer lock side port between the green hub and the clear plastic tubing.Appears to have a narrowing of the tubing within the connection of the hub and clear tubing.No patient harm or impact.Picc inserter noticed leak before insertion so new picc kit was opened, and no leakage or defect was noted from the second kit.
Additional Manufacturer Narrative
Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of an occluded and leaking t-lock assembly was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 4fr dual lumen powerpicc provena catheter.The sample was received with an inlaid stylet and attached t-lock assembly.An attempt to infuse water through the sample through the t-lock assembly revealed the sample to be fully occluded.The occlusion was isolated to the extension tubing.A dripping leak was observed at the junction between the green luer and the t-lock extension tubing.Microscopic inspection of the t-lock revealed material occluding the extension tubing near the proximal end.The material appeared consistent with the adhesive used to bond the luer to the extension tubing.Both the occlusion and the leak was the result of improperly applied adhesive during assembly of the t-lock.Adhesive deposited within the tubing resulted in a complete occlusion while incomplete adhesive on the outside of the tubing left a fluid path for leakage.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.Evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA
• 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: 17596674
• Report Number: 3006260740-2023-03615
• Device Sequence Number: 7552207
• Product Code: LJS
• UDI-Device Identifier: 00801741223310
• UDI-Public: (01)00801741223310
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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): 01/24/2024

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000954A
• Device Lot Number: REGZ2404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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