MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
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 redz1539 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "picc leaking at site when white lumen flushed.When removed, definite slit in picc from 3-4.5 cm mark.Picc inserted (b)(6) 2021 and started leaking (b)(6) 2021" add info rcvd 04/07/2021: explant date: (b)(6) 2021.Placement info: right upper arm.What type of catheter securement was utilized: 5fr securacath 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 leaking catheter was confirmed.The product returned for evaluation was one 6fr t/l powerpicc solo catheter.Usage residues were observed throughout the sample.Compression of the catheter shaft was observed between the 2cm and 5cm depth markings.The compression resulted in a longitudinally aligned ridge-like feature.A split was observed at the top of the ridge.Microscopic inspection of the split revealed a dully granular fracture surface.The split comprised a longitudinally aligned line which exhibited a characteristic misalignment near the proximal end.Compression of the catheter was confirmed in the vicinity of the split.The compression damage, including the formed ridgeline was consistent with features replicated through bench testing, by applying securacath catheter stabilization devices within the taper region of bd powerpicc catheters.The compression and leakage were consistent with damage caused by application of a securacath catheter stabilization device within the taper region of the catheter shaft.These observations were consistent with the event description, which indicated use of a 5fr securacath.Use of catheter stabilization devices that compress the catheter shaft is not recommended.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "picc leaking at site when white lumen flushed.When removed, definite slit in picc from 3-4.5 cm mark.Picc inserted (b)(6) 2021 and started leaking (b)(6) 2021" add info rcvd (b)(6) 2021: explant date: (b)(6) 2021.Placement info: right upper arm what type of catheter securement was utilized: 5fr securacath.Was there patient harm reported?: no.

• Brand Name: POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)
• 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: 11752567
• Report Number: 3006260740-2021-01610
• Device Sequence Number: 19777602
• Product Code: LJS
• UDI-Device Identifier: 00801741028502
• UDI-Public: (01)00801741028502
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 3396355
• Device Lot Number: REDZ1539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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