MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 TLS 5F DL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9295118
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	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeu3526 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported during picc insertion the catheter did not progress.When removed, the nurse found a fragment of the stylet broken in the tip of the catheter.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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged 3cg stylet was confirmed, but the exact cause could not be determined.One 3cg stylet was returned for investigation.The stylet exhibited evidence of use.The white tether wire was unbundled.The stainless wire had been retracted through the septum on the t-lock extension set and the stylet extended 47.5cm from the distal tip of the funnel that was attached to the t-lock extension set.Two obvious kinks were observed in the polyimide tubing.A microscopic examination of the polyimide tubing revealed 6 kinks in the tubing.What appeared to be blood residue was observed within the polyimide tubing.A break was observed in the polyimide tubing near what appeared to be the conductive epoxy tip.The polyimide tubing was 6.85cm in length.The wall thickness of the polyimide tubing was within specification.It was reported that the picc did not progress during insertion.Kinking of the polyimide tubing and advancement against resistance may have been potential contributing factors in the observed damage; however, the exact cause of the reported event could not be determined.The ifu for the 3cg stylet states, ¿ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter end, combined with kinking and excessive forces, may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.¿ h3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported during picc insertion the catheter did not progress.When removed, the nurse found a fragment of the stylet broken in the tip of the catheter.No other information was provided.

• Brand Name: POWERPICC SOLO2 TLS 5F DL
• 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: 11274215
• Report Number: 3006260740-2021-00188
• Device Sequence Number: 1151426
• Product Code: LJS
• UDI-Device Identifier: 00801741028663
• UDI-Public: (01)00801741028663
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/24/2021

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: 9295118
• Device Catalogue Number: 9295118
• Device Lot Number: REEU3526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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