MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC FT CATHETER WITH SHERLOCK 3CG TPS STYLET 5F MBT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2021
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 refp1683 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a fractured picc stylet.It was stated the stylet did not break off.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 lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent stylet is confirmed; however, the exact cause is unknown.One 3cg stylet was returned for evaluation.An initial visual observation showed use residue on the returned sample.Multiple bends were observed in the returned stylet with the most severe bend located approximately 3.5 cm proximal to the epoxy tip.No breaks were observed in the stylet and the distal tip was found to be present and intact.A microscopic observation revealed each bend in the polyimide section of the stylet was between magnets.No breaks or tears were found in the polyimide tubing; however, some whitening of the polyimide material was observed at the most severe bend.Insufficient evidence was found on the returned sample to indicate a specific root cause of the bends and kinks in the stylet; however, possible contributing factors include advancement of the stylet against resistance and damage during manipulation, handling, or use.
Event or Problem Description
It was reported a fractured picc stylet.It was stated the stylet did not break off.No other information was provided.

• Brand Name: POWERPICC FT CATHETER WITH SHERLOCK 3CG TPS STYLET 5F MBT
• 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: 12911107
• Report Number: 3006260740-2021-05090
• Device Sequence Number: 4751396
• Product Code: LJS
• UDI-Device Identifier: 00801741034572
• UDI-Public: (01)00801741034572
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 1275108FD
• Device Lot Number: REFP1683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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