MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT 5 FR D/L PICC 45 CM BASIC KIT; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	7827505
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 rezh2250 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rezh2250) have been reported from two canada facilities.Device has not been returned.
Event or Problem Description
It was reported that the blue tubing (catheter) is allegedly snapping/breaking off right where it starts.There were apparently 3 incidents in the past month.
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 initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.The information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.Therefore this event is deemed not reportable per 21 cfr part 803.

• Brand Name: GROSHONG NXT 5 FR D/L PICC 45 CM BASIC KIT
• 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: 5446033
• Report Number: 3006260740-2016-00042
• Device Sequence Number: 10833483
• Product Code: LJS
• UDI-Device Identifier: 00801741035340
• UDI-Public: (01)00801741035340(17)170828(10)REZH2250
• Combination Product (Y/N): N
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2016

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: 08/28/2017
• Device Catalogue Number: 7827505
• Device Lot Number: REZH2250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2016
• Supplement Report FDA Received Date: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1