MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70CM GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3295155
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reby0890 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "only one side of the hub broke off when breaking the hub apart." no patient injury reported.
Additional Manufacturer Narrative
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 damaged mircointroducer is confirmed but the exact cause is unknown.One peeled 5 fr microintroducer sheath was returned for investigation.One of the tabs was detached from the grey tubing peel.The distal segment of the orange peel tab was broken.Microscopic observation of the break surfaces revealed striation patterns radiating outwards from the center.The break was also observed to be angled and uneven.The segment of the peel tab that broke off showed more material deformation on the outer surface which may have been caused by the use of a gripping instrument.Based on the description of the reported event and condition of the returned sample, possible contributing factors include excessive force during handling or use.The cause of the break could not be determined; therefore, the complaint is confirmed, cause unknown.A lot history review (lhr) of reby0890 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "only one side of the hub broke off when breaking the hub apart." no patient injury reported.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70CM GUIDEWIRE)
• 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: 7664749
• Report Number: 3006260740-2018-01643
• Device Sequence Number: 1409816
• Product Code: LJS
• UDI-Device Identifier: 00801741028113
• UDI-Public: (01)00801741028113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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: 3295155
• Device Catalogue Number: 3295155
• Device Lot Number: REBY0890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1