MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL; 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 Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
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) of reen1981 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported there was a leak in a 3l bard power picc in a micu patient, the leak was in the white port.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), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and was determined to be use related.One 5 fr triple lumen powerpicc provena catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.A longitudinal crease was observed in the catheter between the 0 cm and 3 cm depth markers; the catheter was observed to be slightly flattened at the location of this damage and appeared to have been compressed.A microscopic observation revealed a large longitudinal split in the catheter along the observed crease.The split was measured to be approximately 0.58 inches long and mostly straight.The surfaces of the split were observed to be flat and granular, which is indicative of a tearing failure mode.The cross-section of the split was observed to be elliptical with a distinct point at the location of the split.The location and physical characteristics of the observed split in the returned catheter suggest the catheter was most-likely damaged due to prolonged circumferential compression, which could be caused by some securement devices and/or dressing techniques.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.¿ a lot history review (lhr) of reen1981 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported there was a leak in a 3l bard power picc in a micu patient, the leak was in the white port.No other information was provided.

• Brand Name: POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL
• 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: 10257637
• Report Number: 3006260740-2020-02353
• Device Sequence Number: 3178723
• Product Code: LJS
• UDI-Device Identifier: 00801741034640
• UDI-Public: (01)00801741034640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 1385108Q
• Device Lot Number: REEN1981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 155