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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
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 reer0535 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "two of our vast nurses were inserting a picc on the patient¿s right arm in the icu on (b)(6) 2020 utilizing s1385108d from lot#reer0535.Resistance encountered.Difficulty threading catheter noted from patient anatomy.Few areas of catheter and wire bending with difficulty threading.When abandoning attempt for insertion, small amount of wire noted to proximal catheter tip.Upon withdrawing of wire at the distal end, wire at the proximal end still present.Approximately 1-1.5 inch wire fractured from main wire.Could have been a sentinel event if the wire was unknowingly left inside.No harm done to patient but certainly a near miss.".
Event or Problem Description
It was reported "two of our vast nurses were inserting a picc on the patient¿s right arm in the icu on (b)(6) 2020 utilizing s1385108d from lot#reer0535.Resistance encountered.Difficulty threading catheter noted from patient anatomy.Few areas of catheter and wire bending with difficulty threading.When abandoning attempt for insertion, small amount of wire noted to proximal catheter tip.Upon withdrawing of wire at the distal end, wire at the proximal end still present.Approximately 1-1.5 inch wire fractured from main wire.Could have been a sentinel event if the wire was unknowingly left inside.No harm done to patient but certainly a near miss.".
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken 3cg stylet was confirmed; however, the root cause was not identified.The product returned for evaluation was one 3cg tls stylet.Usage residues were observed throughout the sample.Several kinks and breaks were observed within the polyimide region of the stylet.The received fragments appeared to account for the entire stylet.The sample terminated at the handle assembly.Microscopic inspection of the sample confirmed the presence of multiple kinks and breaks in the polyimide region of the stylet.Deformation and discoloration were observed in the vicinity of breaks and kinks.The polyimide breaks exhibited elliptical cross-sections.The core wire fracture surface appeared dully granular.The polyimide tubing wall thickness was measured at several points and found to be within manufacturing specifications.The deformation suggested that kinking likely contributed to the observed break; however, inability to replicate the break features indicated that an additional unidentified factor(s) likely contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.

• Brand Name: POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG
• 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: 11065949
• Report Number: 3006260740-2020-21071
• Device Sequence Number: 17082330
• Product Code: LJS
• UDI-Device Identifier: 00801741112720
• UDI-Public: (01)00801741112720
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• 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): 02/17/2021

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: S1385108D
• Device Lot Number: REER0535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/18/2021
• 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