MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; 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	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regp2539 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by healthcare professional "i placed a picc yesterday and was called back to facility today due to no blood return and leaking.I noted the picc was leaking at the connection between the hub and the extension tubing.The picc was removed." additional information received 06/30/2022: what type of catheter securement was utilized? statlock date of occurrence: (b)(6) 2022 placement date: (b)(6) 2022 explant date: (b)(6) 2022.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed.The product returned for evaluation was one 4fr s/l powerpicc.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a split was observed in the extension tubing, near the molded joint.Microscopic examination of the catheter split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: ¿ the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.¿ sharply formed fracture edges ¿ planar shape to the fracture surface an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by healthcare professional "i placed a picc yesterday and was called back to facility today due to no blood return and leaking.I noted the picc was leaking at the connection between the hub and the extension tubing.The picc was removed." additional information received 06/30/2022: ¿ what type of catheter securement was utilized? statlock ¿ date of occurrence: (b)(6) 2022 ¿ placement date: (b)(6) 2022 ¿ explant date: (b)(6) 2022.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15006036
• Report Number: 3006260740-2022-02694
• Device Sequence Number: 6819730
• Product Code: LJS
• UDI-Device Identifier: 00801741130861
• UDI-Public: (01)00801741130861
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: TC
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: N/A
• Device Catalogue Number: CK000670
• Device Lot Number: REGP2539
• 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: 06/23/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/08/2022
• 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