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	CK000409A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2020
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 reev1496 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "picc placed on 12/20 external 2 cm.Right brachial placement.12/27 issues with blood return/flushing but could be fixed positionally.12/28 picc was kinking found with xray, was rethreaded by ir, they did not re-access through a new hole.1/1 tpa used and pulled back, no blood return still.1/7 it was removed because they were still having issues.".
Event or Problem Description
It was reported "picc placed on 12/20 external 2 cm.Right brachial placement.12/27 issues with blood return/flushing but could be fixed positionally.12/28 picc was kinking found with xray, was rethreaded by ir, they did not re-access through a new hole.1/1 tpa used and pulled back, no blood return still.1/7 it was removed because they were still having issues.".
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter kink is confirmed but the exact cause remains unknown.One radiographic image of a patient was provided for evaluation.The image appears to show the upper right arm region.A catheter appears to be inserted within the patient¿s arm.Two sharp bends in the catheter tubing appear to be present within the patient¿s arm.Based on the image provided, possible contributing factors include manipulation of the catheter during use and securement method.Since the catheter appeared to be kinked, the complaint is confirmed but the exact cause of the kink remains unknown.H3 other text : evaluation findings are in section h.11.

• 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: 11348767
• Report Number: 3006260740-2021-00390
• Device Sequence Number: 3286605
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: CK000409A
• Device Catalogue Number: CK000409A
• Device Lot Number: REEV1496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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