MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3 FR S/L PER-Q-CATH PLUS INTERMEDIATE TRAY; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	4133110
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reyj0192 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 09/07/2016- per medwatch, it was reported that "upon removal of the picc line after approximately ten days of use, a portion of the picc broke off and was lost in the subcutaneous tissue.On x-ray the line appeared to be entirely within the arm with the tip near the axillary vein.The distal end of the catheter appeared to be near the exit site where the initial picc line had punctured the skin.Despite its close proximity, surgery service was unable to remove the line with local wound exploration.Interventional radiology was required to retrieve the remaining piece of picc line.".

• Brand Name: 3 FR S/L PER-Q-CATH PLUS INTERMEDIATE TRAY
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5971430
• Report Number: 3006260740-2016-00497
• Device Sequence Number: 11118011
• Product Code: LJS
• UDI-Device Identifier: 00801741035227
• UDI-Public: (01)00801741035227(17)160928(10)REYJ0192
• Combination Product (Y/N): N
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2016
• Report Date (Section F): 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2016
• Device Catalogue Number: 4133110
• Device Lot Number: REYJ0192
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 08/11/2016