MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(135CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3396135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a crack in the gray connector was confirmed, and was considered manufacturing related.The implicated and returned product was a 6fr triple-lumen power picc solo.The gray connector was cracked and a 2mm x 1mm x 0.5mm portion of the thread broke away and was not returned for investigation.The valve was still held in place.Cavity ¿o¿ was identified in the gray connector.No cracks were observed on the other connectors.A microscopic examination revealed that the crack had sharp edges and no plastic deformation was observed.A lot history review (lhr) of rebu2114 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Product was returned to bas without any event description or referenced file numbers.No details have been obtained from the attempts made to the facility.Preliminary investigation by fa technician confirmed a cracked hub.

• Brand Name: POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(135CM)
• 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: 7271239
• Report Number: 3006260740-2018-00222
• Device Sequence Number: 10793769
• Product Code: LJS
• UDI-Device Identifier: 00801741028465
• UDI-Public: (01)00801741028465
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3396135
• Device Catalogue Number: 3396135
• Device Lot Number: REBU2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1