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	08/18/2020
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 reep0829 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 blood was flow out from red port.They flushed the red port several time but still same problem.Doctor replaced a new catheter to complete the surgery, replacement finally ok.
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 blood was flow out from red port.They flushed the red port several time but still same problem.Doctor replaced a new catheter to complete the surgery, replacement finally ok.
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 interluminal communication is inconclusive due to the state of the returned sample.One 5 fr dual lumen powerpicc solo catheter was returned for evaluation.An initial visual observation showed use residue throughout and within the returned sample.A microscopic observation revealed a large amount of biological residue around the valve slits of the catheter.An attempt was made to flush both lumens of the returned sample; however, the red lumen of the catheter was found to be partially occluded.No leaks were found during infusion or when the distal tip of the catheter was clamped and each lumen was pressurized.The sample was flushed again and, after biological residue was shifted within and expelled from the catheter, the partially occluded red lumen became fully occluded.No leaks or indications of interluminal communication were found in the returned sample.No interluminal communication could be found within the returned sample; however, the amount of biological residue within the returned catheter may have prevented the alleged issue from being exhibited.Therefore, this complaint is inconclusive due to the state of the returned sample.A lot history review (lhr) of reeq1396 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in hong kong.

• 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: 10574334
• Report Number: 3006260740-2020-03321
• Device Sequence Number: 372884
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 3295335
• Device Lot Number: REEQ1396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/30/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1