MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 4F SL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1194108D2
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refq3397 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported picc stylet broken in multiple places.Additional information received 06/02/2021: placement info: successful line placement.3cg wire removed and as i was going to place neutron on end of picc a wire was hanging (unattached) from inside picc line.I was able to grab what i thought was all of it, place a tourniquet and remove line.Once line was removed the wire was from underneath sheath in sensor area.Wire was missing but sheath still in place.Was there patient harm reported?: no.
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, applicable previous investigation(s), labeling, applicable manufacturing records, returned sample evaluation, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of damaged stylet is confirmed; however, the exact cause is unknown.One 3cg stylet was returned for evaluation.An initial visual observation showed no obvious evidence of use.The portion of polyimide tubing distal of the break site was not returned.Approximately 6 cm of polyimide tubing was still intact proximal of the break site.One kink was observed in the polyimide tubing proximal of the break site.A microscopic observation revealed that no blood residue was observed inside the polyimide tubing.Four magnets were returned outside of the polyimide tubing.The break site was observed to be mostly straight with an uneven fracture surface.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.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported "picc stylet broken in multiple places." add info rcvd 06/02/2021: placement info: successful line placement.3cg wire removed and as i was going to place neutron on end of picc a wire was hanging (unattached) from inside picc line.I was able to grab what i thought was all of it, place a tourniquet and remove line.Once line was removed the wire was from underneath sheath in sensor area.Wire was missing but sheath still in place.Was there patient harm reported?: no.

• Brand Name: POWERPICC SOLO2 4F SL 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: 12009148
• Report Number: 3006260740-2021-02314
• Device Sequence Number: 19659310
• Product Code: LJS
• UDI-Device Identifier: 00801741154881
• UDI-Public: (01)00801741154881
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 08/04/2021

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: 1194108D2
• Device Catalogue Number: 1194108D2
• Device Lot Number: REFQ3397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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