MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 5F MAXIMAL BARRIER TRAY (DUAL-LUMEN) (55CM) (WITH MICROINTROD; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged vessel dilator was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a vessel dilator.Usage residues were observed throughout the device and a syringe was attached to the luer adapter.The dilator shaft was either broken or detached from the luer portion of the device.The tip of the dilator exhibited curved shape memory.While damage was obvious in the returned photograph, inspection of that photograph was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of recz0587 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The rn that placed the picc reported, "uneventful insertion up to the point when i removed the inner core from micro introducer to insert picc.The gray, needle like part remained in the sheath and was completely apart from its twist hub.I was able to grab it and remove from the sheath.The pt was not harmed during event.".

• Brand Name: POWERPICC CATHETER 5F MAXIMAL BARRIER TRAY (DUAL-LUMEN) (55CM) (WITH MICROINTROD
• 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: 8675665
• Report Number: 3006260740-2019-01564
• Device Sequence Number: 14041977
• Product Code: LJS
• UDI-Device Identifier: 00801741028717
• UDI-Public: (01)00801741028717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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 Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000057
• Device Lot Number: RECZ0587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1