MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 4F DL MAX; 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
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 reew2983 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the stylet unraveled when retracting from picc.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, 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 that the stylet unraveled while removing it from the picc was confirmed.The product returned for evaluation was one braided stylet.The coil wire on the stylet was elongated and unraveled, making the overall length of the returned sample 68.9¿.Microscopic examination of the distal end of the device revealed that the weld tip was completely detached from the sample and was not returned for evaluation.Two coils near the distal end of the sample were compressed and deformed.Neither the coil wire nor the core wire contained thinning or necking of the wire material.The end of the coil and core wires contained a flat plane that was angled with respect to the axis of the wire.No major kinks or bends were noted in the core wire of the stylet.The t-lock assembly was found on the stylet.The coils of the coil wire were tightly coiled distal of the t-lock assembly but were elongated proximal of the t-lock assembly.This indicated that the friction of pulling the stylet through the t-lock assembly caused the wire to elongate, once the inner core wire and coil wire had become detached from each other.The microscopic characteristics of flat surface planes, lack of material necking, and deformed coils on the coil wire are indicative of the stylet being cut with a sharp instrument.This will often occur if the stylet is not retracted far enough prior to trimming the catheter.The hang tag on the device warns, ¿do not cut stylet-withdraw stylet before trimming catheter¿.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported the stylet unraveled when retracting from picc.No other information was provided.

• Brand Name: DOT PROV 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: 11938982
• Report Number: 3006260740-2021-02178
• Device Sequence Number: 3755127
• Product Code: LJS
• UDI-Device Identifier: 00801741130403
• UDI-Public: (01)00801741130403
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/28/2021

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: S3274108D
• Device Lot Number: REEW2983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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