MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regp1717 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "picc catheter with a hole below the red lumen near the valve portion of the catheter.".
Event or Problem Description
It was reported by the customer "picc catheter with a hole below the red lumen near the valve portion of the catheter".
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed.One 5 fr dual lumen powerpicc solo catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.When the catheter lumens were pressurized with water, and a spraying leak was observed in the extension tubing of the red lumen, approximately 0.5 cm distal to the hub.A microscopic observation revealed a very small split in the extension leg tubing of the red lumen.A superficial abrasion was observed just proximal to and aligned with this split.The split was observed to taper radially with the exterior side of the split being longer than the interior side, suggesting the damage originated from an exterior source.The edges of the split were observed to be mostly straight with slightly curved corners.The fracture surfaces of the split were observed to be somewhat rough in texture, but mostly flat and even.The shape, location, and characteristics of the split and the surrounding area suggest the catheter tubing was likely damaged due to contact with a sharp, pointed, and/or metallic object.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG
• 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: 15262401
• Report Number: 3006260740-2022-03248
• Device Sequence Number: 5602741
• Product Code: LJS
• UDI-Device Identifier: 00801741029035
• UDI-Public: (01)00801741029035
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 09/27/2022

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 Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CK000314
• Device Lot Number: REGP1717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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