MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER & BELDAR NEEDLE; 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)
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 ¿broken introducer needle¿ was confirmed but the exact cause was unknown.The product returned for evaluation was a 21ga safecan introducer needle.The needle was returned detached, not broken, from the luer hub and safety mechanism.Gross visual evaluation of the sample found blood-like usage residue throughout.The safety mechanism clip and can were both unremarkable.Microscopic examination of the interfacing needle cannula and luer hub found no damage or other noteworthy observations on the needle and the luer hub contained an appropriate application of adhesive, both in quantity and workmanship.The edge of the adhesive fillet was cleanly formed and unremarkable.The needle diameter measured to be within specification.While the event could be confirmed based on the state of the sample, no potential evidence supporting a root cause was found.A lot history review (lhr) of recq0277 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the introducer needle was broken.No other information is available.

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER & BELDAR NEEDLE
• 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: 8161483
• Report Number: 3006260740-2018-03573
• Device Sequence Number: 2879123
• Product Code: LJS
• UDI-Device Identifier: 00801741154935
• UDI-Public: (01)00801741154935
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1174108D3
• Device Lot Number: RECQ0277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1