MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SOLO 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	03/23/2021
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 refn1977 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "fractured wire on picc insertion, picc placement was unsuccessful" additional information received 03/28/2021: "there was no harm to the patient." no other information was provided.
Event or Problem Description
It was reported "fractured wire on picc insertion, picc placement was unsuccessful" additional information received 03/28/2021: "there was no harm to the patient".No other information was provided.
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 analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of stylet damage was confirmed but the cause was unknown.The product returned for evaluation was a 4fr d/l powerpicc provena catheter and a 3cg stylet.Both pieces contained evidence of use, including blood-like residue, and a broken segment of stylet was seen protruding from the distal end of the catheter.Microscopic examination of the fracture region of the stylet found that both ends contained kinking between the magnet joints, overall curling of the magnet tip, and associated curling of the inner core support wire.Breaks in magnets were also seen in the same region.No potential manufacture damage, defect, or deformity was seen on the sample.The polyimide tubing was confirmed to be within manufacture specification.The observed fracture features were indicative of catheter and/or stylet kinking, with stylet drag about a relatively tight radius resulting in curling of the wire, and likely occurred during the insertion process.However, the exact circumstances providing for that type of event were ultimately unknown.

• Brand Name: DOT PROV SOLO 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
• MDR Report Key: 11675928
• Report Number: 3006260740-2021-01350
• Device Sequence Number: 3095745
• Product Code: LJS
• UDI-Device Identifier: 00801741130373
• UDI-Public: (01)00801741130373
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: S1294108D
• Device Lot Number: REFN1977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other