MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER WITH SHERLOCK 3CG TPS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported "writer called to assess picc line this morning.Rn stated that when distal port of picc line was flushed that biopatch and dressing became saturated.Writer assessed line and agreed with assessment.Writer and rn spoke with covering team and decision was made to d/c picc and see how patient would do.Piv placed for antibiotics and picc line d/c'd.When picc removed there was a twist in the catheter and visible hole in distal portion of picc line.Patient scheduled for sedation on thursday morning in case picc line needs to be replaced." did event occur during placement, during removal, or after removal? "while in-dwelling".
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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed; however, the exact cause is unknown.One 4 fr dual lumen powerpicc sv and one non-bd 4 fr securacath were returned for evaluation.An initial visual observation showed use residue on the returned samples.A large longitudinal split was observed in the catheter around the 2 cm depth marker.The catheter was observed to be twisted at the location of this split.A kink was observed in the catheter between the 3 cm and 4 cm depth markers.A microscopic observation revealed the split in the catheter aligned with one peak of the twist in the catheter tubing.The edges of the split were observed to be quite rough and granular in texture.Additional damage was observed on the surface of the catheter between the two peaks of the twist in the catheter.The catheter tubing appeared to be somewhat flatter between the twist and the kink in the catheter between the 3 cm and 4 cm depth markers.The features of the observed split suggest the catheter was likely damaged due to prolonged circumferential compression, which could be caused by some dressing techniques and/or positioning of the catheter.However, the exact cause of the damage observed in the returned catheter could not be determined.As a note, the product ifu states: ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ h3 : evaluation findings are in section h.11.
Event or Problem Description
It was reported "writer called to assess picc line this morning.Rn stated that when distal port of picc line was flushed that biopatch and dressing became saturated.Writer assessed line and agreed with assessment.Writer and rn spoke with covering team and decision was made to d/c picc and see how patient would do.Piv placed for antibiotics and picc line d/c'd.When picc removed there was a twist in the catheter and visible hole in distal portion of picc line.Patient scheduled for sedation on thursday morning in case picc line needs to be replaced.".Did event occur during placement, during removal, or after removal? "while in-dwelling".

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TPS
• 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: 10886540
• Report Number: 3006260740-2020-20646
• Device Sequence Number: 1154314
• Product Code: LJS
• UDI-Device Identifier: 00801741087110
• UDI-Public: (01)00801741087110
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 1274108D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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