MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER 4F FULL TRAY (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebu1868 showed one other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported by icu rn, "leaking from the white lumen on (b)(6) 2019, line clamped and secured, pt unable to be sedated for replacement, red lumen in use at the time.Icu rn reported red lumen leaking and removed the picc.Pt already scheduled for line replacement that day, second line placed before the initial line was removed.Picc team and icu staff state there were no mechanical issues during placement, use, or removal other than the hubs leaking as described.Picc was exposed to cathflo on four occasions prior to leaking incident ¿ lumen(s) note noted.Pt experienced a delay in treatment, is currently an inpatient in the icu, complete dx unknown at this time.Icu nurse expressed anxiety over impact to pt care.".
Event or Problem Description
It was reported by icu rn, "leaking from the white lumen on (b)(6) 2019, line clamped and secured, pt unable to be sedated for replacement, red lumen in use at the time.Icu rn reported red lumen leaking and removed the picc.Pt already scheduled for line replacement that day, second line placed before the initial line was removed.Picc team and icu staff state there were no mechanical issues during placement, use, or removal other than the hubs leaking as described.Picc was exposed to cathflo on four occasions prior to leaking incident ¿ lumen(s) note noted.Pt experienced a delay in treatment, is currently an inpatient in the icu, complete dx unknown at this time.Icu nurse expressed anxiety over impact to pt care.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leaking catheter is confirmed; however the exact cause is unknown.One 4 fr dual lumen powerpicc sv was returned for evaluation.An initial visual observation showed use residue throughout the returned sample.Splits were observed in the extension tubing of both lumens, just within the distal end of the luer hubs.A microscopic observation revealed the fracture surface of the splits was rough and exhibited cracks/fissures and beach marks, which are suggestive of material fatigue.The tubing material was observed to be attached to the luer connector at irregular points along the tubing¿s circumference in both lumens, and cracking appeared to have initiated at one or more of these points.While the exact cause of the splits observed in the extension tubing of the returned sample is unknown, possible contributing factors include pulling, twisting, and manipulating the luer connector hub and/or extension leg.A lot history review (lhr) of rebu1868 showed one other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SV CATHETER 4F FULL TRAY (DUAL-LUMEN)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8379923
• Report Number: 3006260740-2019-00426
• Device Sequence Number: 11325123
• Product Code: LJS
• UDI-Device Identifier: 00801741027826
• UDI-Public: (01)00801741027826
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: 3274108
• Device Lot Number: REBU1868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1