MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GUI; 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	11/26/2019
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 redn0179 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after placed the catheter into patient, they tried to flush it and found that when they pushed saline into purple port, some saline was flow out from red port while pushing the saline in.Doctor replaced a new catheter to complete the surgery.
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 unconfirmed as the reported problem could not be reproduced.One 5 fr dual lumen powerpicc solo was returned for evaluation.An initial visual observation showed use residue on the returned sample.Both lumens of the sample were flushed and pressurized with a 12 ml syringe of water; however, no leaks were observed.No backflow was observed from the opposite lumen when one lumen was flushed while the distal tip of the catheter was occluded.Both lumens were found to be patent to infusion and aspiration and no leakage was observed from the valve of either lumen.A microscopic observation revealed no damage on the returned catheter.A lot history review (lhr) of redn0179 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after placed the catheter into patient, they tried to flush it and found that when they pushed saline into purple port, some saline was flow out from red port while pushing the saline in.Doctor replaced a new catheter to complete the surgery.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GUI
• 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: 9496230
• Report Number: 3006260740-2019-03934
• Device Sequence Number: 1304953
• Product Code: LJS
• UDI-Device Identifier: 00801741028120
• UDI-Public: (01)00801741028120
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K072230
• 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): 01/31/2020

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: 3295335
• Device Lot Number: REDN0179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1