MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) of regt1708 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the patient requesting assistance identifying a 5cm clear "sheath" on the outside of her removed powerpicc solo catheter.States she is immunocompromised and has been getting her picc removed and replaced every 84 days.States she is also an epidemiologist and has been receiving ivig infusions for many years.She is concerned on what could be on the outside of the catheter and if it due to user error during placement as she has never seen this before.Has no complaints or symptoms.
Event or Problem Description
It was reported the patient requesting assistance identifying a 5cm clear "sheath" on the outside of her removed powerpicc solo catheter.States she is immunocompromised and has been getting her picc removed and replaced every 84 days.States she is also an epidemiologist and has been receiving ivig infusions for many years.She is concerned on what could be on the outside of the catheter and if it due to user error during placement as she has never seen this before.Has no complaints or symptoms.
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 foreign material on the catheter was confirmed but the cause is unknown.A series of four photographs of the implicated 5fr d/l powerpicc solo catheter were returned for evaluation.A clear foreign material was seen around the powerpicc catheter shaft.The foreign material appeared to be approximately 5cm long and was located from about the 13cm depth marking through the 18cm depth marking.The thickness of the clear material appeared uneven.The ends of the clear material contained some reddish discoloration, and a fibrous texture was seen on one end of the material.Without receipt of the physical sample, the foreign material could not be conclusively identified.Possible contributing factors for the foreign material could include catheter handling (e.G., contamination on the catheter) or biological material on the catheter (e.G., fibrin sheath).A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN)
• 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: 16475498
• Report Number: 3006260740-2023-00619
• Device Sequence Number: 15285119
• Product Code: LJS
• UDI-Device Identifier: 00801741028144
• UDI-Public: (01)00801741028144
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/17/2023

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: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 3295355
• Device Lot Number: REGT1708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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