MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SP 4F DL MAX; 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	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reev2082 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "3fr.Picc that had a broken wire over the weekend." additional info.Received 09/14/2021 "difficulty advancing picc, noted to have broken wire after multiple attempts to pass through introducer.When pulled out, wire noted to be broken, other piece of wire retrieved from picc.".
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet was confirmed but the cause is unknown.The products returned for evaluation were a 4fr d/l powerpicc catheter and two segments of a 3cg stylet.The catheter appeared undamaged.A functional test revealed that the catheter was patent to infusion and no leaks were detected.One of the returned stylet segments was returned within the catheter lumen and the distal tip of the stylet protruded beyond the tip of the catheter.When the stylet segment was removed from the catheter, kinking was observed in the plastic tubing of the stylet.The wall thickness of the polyimide tubing and the outer diameter of the core wire met the device specifications.The other returned stylet segment was found outside the catheter.This segment was 6.1¿ long and contained part of the magnetic region of the stylet and part of the solid core wire section.The magnetic region of this segment contained a severe kink 0.44¿ from the break site.The plastic tubing of the stylet was deformed into an elliptical shape, indicating that the tubing had likely kinked prior to breaking.It was reported that difficulty was encountered when advancing the picc; however, the cause of the initial difficulty during advancement could not be determined.It is possible that the difficult placement was a contributing factor in the stylet break; however, it is unknown if additional unknown factors contributed to this event.Other possible contributing factors include retracting the stylet through the t-lock assembly or the stylet extending beyond the catheter tip.H3 other text : device evaluation findings are in the manufacturer's note.
Event or Problem Description
It was reported "3fr.Picc that had a broken wire over the weekend." additional info.Received (b)(6) 2021 "difficulty advancing picc, noted to have broken wire after multiple attempts to pass through introducer.When pulled out, wire noted to be broken, other piece of wire retrieved from picc.".

• Brand Name: DOT PROV SP 4F DL MAX
• 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: 12591016
• Report Number: 3006260740-2021-04212
• Device Sequence Number: 4380573
• Product Code: LJS
• UDI-Device Identifier: 00801741134166
• UDI-Public: (01)00801741134166
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: S1274108PD
• Device Lot Number: REEV2082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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 Age: 14 YR
• Patient Sex: Male