MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PPICC SOLO PROVENA 4F DL 3CG; 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	04/02/2021
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 reev1496 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "attempted picc placement - able to access vein and thread wire without difficulty but unable to pass picc past ~20 cm marking.Unable to advance or retract picc or inner wire.Attending physician and vascular surgery physician notified.Vascular physician to bedside and able to remove picc.Picc catheter and guidewire intact but guidewire was kinked and frayed in several areas." add info rcvd d 05/03/2021: placement info: right brachial vein 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, 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 damaged stylet was confirmed; however, the root cause was not identified.The product returned for evaluation was one 5fr d/l powerpicc solo catheter.The sample was received with an inlaid 3cg stylet.The polyimide region of the stylet extended past the tip of the trimmed catheter.Kinks were observed between nearly every magnet within the polyimide region.Two complete breaks were observed in the polyimide tubing.The core wire was intact and the complete stylet was returned.Microscopic inspection of the stylet confirmed extensive deformation throughout the polyimide region.The breaks in the polyimide tubing exhibited granular fracture surfaces.The stylet exhibited elliptical cross-sections, material buckling and discoloration at the break sites.The polyimide tubing wall thickness was measured at several points and found to be within manufacturing specifications.Kinking of the polyimide tubing, advancement past the tip of the catheter during insertion and advancement against resistance may have been 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.¿.
Event or Problem Description
It was reported "attempted picc placement - able to access vein and thread wire without difficulty but unable to pass picc past ~20 cm marking.Unable to advance or retract picc or inner wire.Attending physician and vascular surgery physician notified.Vascular physician to bedside and able to remove picc.Picc catheter and guidewire intact but guidewire was kinked and frayed in several areas." add info rcvd d 05/03/2021: placement info: right brachial vein.Was there patient harm reported?: no.Medwatch received stated: picc catheter intact, unable to advance, catheter removed, inner wire was kinked and frayed in several areas.

• Brand Name: DOT PPICC SOLO PROVENA 4F DL 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: 11821321
• Report Number: 3006260740-2021-01830
• Device Sequence Number: 3248920
• Product Code: LJS
• UDI-Device Identifier: 00801741215070
• UDI-Public: (01)00801741215070
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 06/30/2021

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: CK000409A
• Device Lot Number: REEV1496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/29/2021
• 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