MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO FT CATHETER 5F FULL TRAY DL MAXIMAL BARRIER 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	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that they are having issues with pulling air in piccs when they are checking for blood return.There seems to be a leak in the stiffening wire lumen that causes air to pull and not blood.Response received 13 sep 2023: this pulls air into the saline syringe when aspirating for blood return.It also causes saline to leak out of the rubber stopper where the stiffening wire exits.It also causes the blood return check to be misleading, therefore leading the inserter to believe that the picc is not in the proper location.We have noticed this occurring during multiple insertions.No injury has occurred to patients, but potentially could lead to a malpositioned picc placement or expelling air from the syringe into the patient's central venous system.A specific number of affected devices or patients was not provided by the complainant.
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 will evaluate.Results are expected soon.
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.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported by customer that they are having issues with pulling air in piccs when they are checking for blood return.There seems to be a leak in the stiffening wire lumen that causes air to pull and not blood.Response received 13 sep 2023 : this pulls air into the saline syringe when aspirating for blood return.It also causes saline to leak out of the rubber stopper where the stiffening wire exits.It also causes the blood return check to be misleading, therefore leading the inserter to believe that the picc is not in the proper location.We have noticed this occurring during multiple insertions.No injury has occurred to patients, but potentially could lead to a malpositioned picc placement or expelling air from the syringe into the patient's central venous system.A specific number of affected devices or patients was not provided by the complainant.Additional information received: there's no sample to be returned since they have been inserted on patients.

• Brand Name: POWERPICC SOLO FT CATHETER 5F FULL TRAY DL MAXIMAL BARRIER 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: 17800129
• Report Number: 3006260740-2023-04262
• Device Sequence Number: 12501078
• Product Code: LJS
• UDI-Device Identifier: 00801741028052
• UDI-Public: (01)00801741028052
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 3295108D
• Device Lot Number: REHQ1011
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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