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

Model Number	3175335
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refy3552 showed five other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer leaking picc.It was stated the picc was checked and it didn't seem to be cracked.It's like there is a problem with the threading.
Event or Problem Description
It was reported by the customer leaking picc.It was stated the picc was checked and it didn't seem to be cracked.It's like there is a problem with the threading.Additional information received: picc line is leaking between the end of the picc and the clave.¿ what type of catheter securement was utilized? stat-lok.¿ date of occurrence: jun 22/22¿ placement date: jun 14/22.¿ explant date: picc still in place.¿ was there any patient harm reported: no.
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, manufacture quality and production records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed, and the cause was manufacturing-related.The product returned for evaluation was one 5fr s/l powerpicc catheter.Light usage residues were observed throughout the sample and a needleless injection cap was attached to the luer adapter.Microscopic inspection of the luer adapter revealed a protrusion in the luer material within the orifice.That material had the appearance of a mold defect which could result in inadequate sealing of the luer hub with a syringe.Bd is working closely with the manufacture facility to prevent recurrence of this event.

• Brand Name: POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC 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: 15004583
• Report Number: 3006260740-2022-02678
• Device Sequence Number: 13897364
• Product Code: LJS
• UDI-Device Identifier: 00801741027697
• UDI-Public: (01)00801741027697
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033389
• 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): 08/31/2022

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 Model Number: 3175335
• Device Catalogue Number: 3175335
• Device Lot Number: REFY3552
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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