MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (70 CM GUID; 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	07/24/2020
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 reeq0588 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the picc was placed on 7/23, ref # 3174155, lot reeq0588 for a patient requiring tpn and secured with sutures.It was discovered that the luer lock hub was leaking on 7/24 and the patient had a picc line exchange done with a different lot number.No harm to the patient was reported.
Event or Problem Description
It was reported the picc was placed on 7/23, ref # 3174155, lot reeq0588 for a patient requiring tpn and secured with sutures.It was discovered that the luer lock hub was leaking on 7/24 and the patient had a picc line exchange done with a different lot number.No harm to the patient was reported.
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 leaking hub is unconfirmed as the alleged issue could not be reproduced.One 4 fr single lumen powerpicc was returned for evaluation.An initial visual observation showed use residue on the returned sample.The pinch clamp on the extension leg tubing was observed to be engaged.The sample was flushed and pressurized with a 12 ml luer lock syringe of water as well as with a 12ml slip-fit syringe of water.No leaks were found with the infusion and pressurization of either syringe, and the catheter was found to be patent to infusion and aspiration.A microscopic observation revealed no cracks or major damage on the luer hub, and no damage was observed on the extension leg, molded joint, or shaft of the catheter.While the alleged problem was unable to be reproduced with the returned sample, an incomplete or incorrect connection to the luer hub could allow for some leakage between the luer hub and the connected device; however, this was not able to be replicated during evaluation.A lot history review (lhr) of reeq0588 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (70 CM GUID
• 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: 10434881
• Report Number: 3006260740-2020-02999
• Device Sequence Number: 3218937
• Product Code: LJS
• UDI-Device Identifier: 00801741027611
• UDI-Public: (01)00801741027611
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 09/29/2020

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 Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 3174155
• Device Lot Number: REEQ0588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 72