MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 3F SL MBPLUS (3CG, BIOPATCH, PROBE COVER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer "they had an incident where the sherlock 3cg stylet wire broke off and was found on chest x-ray.She stated that this happened today, (b)(6)2022.".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the customer "they had an incident where the sherlock 3cg stylet wire broke off and was found on chest x-ray." she stated that this happened today, 11/17/2022.Per medwatch: "after placement of picc, noted guidewire fragment in pulmonary vessel.Insertion guidewire in sharps container.Wire fragment appears to have broken off the 3cg wire which is located inside the picc line.Wire fragment retrieved by interventional cardiology.".
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 is pending evaluation.Results are expected soon.A lot history review (lhr) of regu1698 showed no other similar product complaint(s) from this lot number.
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 (if available), complaint and lot history review, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet is confirmed.One segment of a 3cg stylet was returned for evaluation.An initial visual observation showed use residue on the returned sample.The segment was found to be approximately 1.9 cm long, and the epoxy tip of the stylet was not found on the returned segment.A kink was observed in the stylet segment near one end.A microscopic observation revealed the break site nearest the kink in the stylet segment was flat and distinct with a relatively small amount of plastic deformation and delamination on one side of the break surface.Striations were observed on this fracture surface directly across from the area of the break site which exhibited plastic deformation.A relatively large amount of plastic deformation was observed at the other break site; however, striations were observed on a flat portion of this break site directly across from the largest area of plastic deformation at this break site as well.The flattest areas of the break sites were also observed to be smooth and somewhat lustrous.The striations observed on the flat and lustrous portions of the break sites suggest the stylet was damaged by a sharp instrument before ultimately breaking due to forces encountered during handling and/or placement of the device.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer "they had an incident where the sherlock 3cg stylet wire broke off and was found on chest x-ray." she stated that this happened today, (b)(6) 2022.Per medwatch: "after placement of picc, noted guidewire fragment in pulmonary vessel.Insertion guidewire in sharps container.Wire fragment appears to have broken off the 3cg wire which is located inside the picc line.Wire fragment retrieved by interventional cardiology.".

• Brand Name: POWERPICC PROVENA 3F SL MBPLUS (3CG, BIOPATCH, 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15933586
• Report Number: 3006260740-2022-05611
• Device Sequence Number: 6535517
• Product Code: LJS
• UDI-Device Identifier: 00801741155031
• UDI-Public: (01)00801741155031
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1173108D4
• Device Lot Number: REGU1698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 12/29/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 12/15/2022; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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: Required Intervention
• Patient Sex: Unknown