MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refx2579 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "we had a patient with a triple lumen picc and after a couple days, the white end of the one lumen came off." 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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached luer hub is confirmed; however, the exact cause is unknown.One 5 fr triple lumen powerpicc provena catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.The white luer hub was found to be completely detached with some of the extension leg tubing visible within the distal end of the hub.An indentation was observed in the extension leg of the white lumen about 2 mm distal to the break site.A microscopic observation revealed the break site of the extension leg tubing in the white lumen was at an angle with slightly flared edges.The surfaces of the break were observed to be mostly smooth and flat except for one side of the break which was found to be rough and uneven.Some beach markings were observed on this rough section of the break surface.A small, superficial split was observed in the extension leg tubing just proximal to the indentation observed about 2 mm distal to the break site.Striations were observed on the surface of this superficial split, which suggest contact with a sharpened instrument; however, this could not be confirmed.While the exact cause of the detached luer hub could not be determined, possible causes include sharp instrument damage, material fatigue, and excessive pulling and/or twisting of the luer hub.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "we had a patient with a triple lumen picc and after a couple days, the white end of the one lumen came off." add info received: triple lumen picc placed on patient on 1/27/2022 without difficulty or issue.Request to place new line on 01/29/2022 due to white plastic end piece having come off.This picc was secured with statlock.No harm to patient occurred.Patient hospitalized for covid.

• Brand Name: POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13546150
• Report Number: 3006260740-2022-00365
• Device Sequence Number: 17412108
• Product Code: LJS
• UDI-Device Identifier: 00801741155079
• UDI-Public: (01)00801741155079
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: S1385108D4
• Device Lot Number: REFX2579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male