MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 4F FULL TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint that the catheter caused or contributed to the reported leak was unconfirmed since no leak could be replicated within the device.One 4fr single lumen powerpicc was returned for investigation.The catheter exhibited evidence of use.The tubing had been trimmed to length near the 35cm depth mark.Both a functional test and a microscopic examination revealed no breaches in any part of the catheter.Since no leaks could be replicated in the device, the complaint that the powerpicc was damaged was unconfirmed and there was no indication that the manufacturing process caused the reported problem.The reported leaking from the insertion site could be associated with a fibrin sheath; however, the source and mechanism of the reported leak was unknown.What appeared to be consistent with fibrin sheath material was adhered within the distal tip of the catheter.A sliver of loose material remained attached to the distal tip of the picc.When trimming the picc to length, the instructions for use state, ¿inspect cut surface to assure there is no loose material.¿ a lot history review (lhr) of recz2921 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that 4 fr single lumen powerpicc was placed in the right arm, brachial vein; 5 cm external length, securacath in place.On (b)(6) 2019, vascular access team was called to assess 4fr single lumen power picc to right upper arm placed on (b)(6) 2019 for possible leaking.Picc line flushed with 10ml ns and no leaking noted.Dressing was removed and biopatch was noted to be saturated with serous fluid.Once the dressing was removed the picc was flushed with 20ml ns with direct observation of insertion site.No leaking noted.The securacath was removed to assess for fracture and the picc was pulled back 1cm to assess for leaking.None noted.The dressing was applied.Discussed with the bedside rn that the picc was ok to use for now.If the picc appears to be leaking or any other concerns stop the infusion and place a piv.Will have further discussions if long term access is needed.On (b)(6) 2019, the vascular access team was contacted again due to persistent leaking from the site; unknown source of leakage.Picc was removed.No patient harm reported.

• Brand Name: POWERPICC CATHETER 4F FULL TRAY (SINGLE-LUMEN)
• 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: 8851674
• Report Number: 3006260740-2019-02275
• Device Sequence Number: 1746408
• Product Code: LJS
• UDI-Device Identifier: 00801741027574
• UDI-Public: (01)00801741027574
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/01/2019

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: 3174108
• Device Lot Number: RECZ2921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 53