MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported, "we were placing a picc and when we went to push the wire back through the picc after cutting the picc to measured length, it was noticed that the picc wire (2 inches from the end) was broken and hanging on by a thread.The wire eventually fully snapped and broke off with (b)(6) touching it".Additional information received (b)(6)2023: "the internal picc wire was broken and hinged prior to inserting picc line so no pieces were retained in the patient or needing retrieval.".
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.Based on a review of this information, the following was concluded: the complaint of broken stylet is confirmed and was determined to be use related.One 3cg stylet within a 4 fr single lumen powerpicc catheter was returned for evaluation.An initial visual observation showed a break in the stylet near the proximal end of the stylet tubing.The distal end of the stylet was missing and was not returned for evaluation.A microscopic observation revealed plastic deformation and some delamination of the stylet tubing at the break site of the stylet.The break site of the core wire of the stylet was observed to be tapered.One magnet was found to remain in the stylet tubing and this magnet was observed to be cracked near its distal end.The majority of the fracture surface of the stylet tubing was observed to be rough and uneven; however, one small section was observed to be flat, smooth, and lustrous with some slight striations, which suggests the stylet may have been initially damaged by a sharp instrument such as scissors.This weakened portion of the stylet likely then kinked and ultimately broke with subsequent movement of the stylet.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, "we were placing a picc and when we went to push the wire back through the picc after cutting the picc to measured length, it was noticed that the picc wire (2 inches from the end) was broken and hanging on by a thread.The wire eventually fully snapped and broke off with nurse touching it." additional information received 06/02/2023: "the internal picc wire was broken and hinged prior to inserting picc line so no pieces were retained in the patient or needing retrieval.".

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER
• 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: 17122283
• Report Number: 3006260740-2023-02421
• Device Sequence Number: 7434339
• Product Code: LJS
• UDI-Device Identifier: 00801741154935
• UDI-Public: (01)00801741154935
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• 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): 10/19/2023

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 1174108D3
• Device Lot Number: REHP0173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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