MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; 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	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported "picc was inserted using the stylet on cxr, noted foreign body at the subclavian.3cm of stylet wire.Patient will be transferred to interventional radiology for removal." 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 broken 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.The distal end of the stylet was observed to be missing and only approximately 4.7 cm of the polyimide of the stylet was found to remain.A microscopic observation revealed the break in the polyimide tubing was uneven with a rough surface texture and some plastic deformation.Many kinks were observed in the polyimide tubing and were each found to be between magnet interfaces.The observed fracture features were indicative of catheter and/or stylet kinking, which likely occurred during the insertion process.However, the exact circumstances providing for that type of event were ultimately unknown.A lot history review (lhr) of refn0701 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "picc was inserted using the stylet on cxr, noted foreign body at the subclavian.3cm of stylet wire.Patient will be transferred to interventional radiology for removal." no other information was provided.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• 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: 12049951
• Report Number: 3006260740-2021-02406
• Device Sequence Number: 3593086
• Product Code: LJS
• UDI-Device Identifier: 00801741028618
• UDI-Public: (01)00801741028618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• 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): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2194108
• Device Lot Number: REFN0701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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: Required Intervention