MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DECOMPRESSION TUBE 18F 3.4CM; TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number	000352
Health Effect - Clinical Code	No Information (3190)
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 for evaluation.A lot history review (lhr) of huax1481 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
As reported by the facility to ms&s, "customer reports the button decompression tip broke when they inserted it into the patient's button.".

• Brand Name: DECOMPRESSION TUBE 18F 3.4CM
• Common Device Name: TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6446432
• Report Number: 3006260740-2017-00335
• Device Sequence Number: 1378218
• Product Code: KGC
• UDI-Device Identifier: 00801741080968
• UDI-Public: (01)00801741080968(17)180428(10)HUAX1481
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2017

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: 04/28/2018
• Device Catalogue Number: 000352
• Device Lot Number: HUAX1481
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1