MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 4F DL MAX 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	08/06/2021
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 refp4110 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported "picc line was attempted for insertion into right arm.Upon advancing picc catheter into vessel on the first attempt, difficulty noted passing over shoulder.Picc line removed and internal wire noted to be curved approximately 3 inches before the tip.Internal wire inserted back into picc line and second insertion attempted.Again resistance noted while trying to pass the shoulder.Upon attempting to remove catheter some resistance noted, probable vessel spasm.Picc was able to be slowly removed intact.Upon inspecting internal wire, it was noted to be bent in two places.Picc line attempt aborted on this arm.Upon placing faulty wire in bag, part of wire actually broke off.No injury whatsoever to patient." this report addresses the first attempt.
Event or Problem Description
It was reported "picc line was attempted for insertion into right arm.Upon advancing picc catheter into vessel on the first attempt, difficulty noted passing over shoulder.Picc line removed and internal wire noted to be curved approximately 3 inches before the tip.Internal wire inserted back into picc line and second insertion attempted.Again resistance noted while trying to pass the shoulder.Upon attempting to remove catheter some resistance noted, probable vessel spasm.Picc was able to be slowly removed intact.Upon inspecting internal wire, it was noted to be bent in two places.Picc line attempt aborted on this arm.Upon placing faulty wire in bag, part of wire actually broke off.No injury whatsoever to patient." this report addresses the first attempt.
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 damaged 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 returned stylet was observed to be broken into three pieces approximately 4.4 and 4.9 cm proximal to its distal tip.The epoxy tip of the stylet was observed present and intact on the distal segment.The core wire was observed to be protruding from the most distal break site.The stylet was returned threaded through a t-lock and this t-lock was observed to be positioned approximately 25.5 cm distal to the yellow handle of the stylet.Multiple bends and kinks were observed in the returned stylet.A microscopic observation revealed the break sites in the polyimide tubing were uneven with a rough surface texture and plastic deformation.Some tapering and delamination were observed in the polyimide tubing at the break sites.The observed fracture features were indicative of catheter and/or stylet kinking, with stylet drag about a relatively tight radius resulting in curling of the wire, and 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.

• Brand Name: DOT PROV 4F DL MAX 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: 12380201
• Report Number: 3006260740-2021-03588
• Device Sequence Number: 17244968
• Product Code: LJS
• UDI-Device Identifier: 00801741130366
• UDI-Public: (01)00801741130366
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1274108D
• Device Lot Number: REFP4110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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