MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD® NASOGASTRIC SUMP TUBE; NG TUBE

Catalog Number	0042160
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that after the nasogastric (ng) tube was placed, the patient went home and the ng tube became dislodged the day after.The patient allegedly went back to the hospital to have an additional surgery to replace the ng tube.The attending physician believed that the portion of the balloon where there was glue seemed as if it had peeled off and flipped on itself; deflating the balloon and causing it to fall out.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as per additional information received the alleged device is not sold by bard medical.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.
Event or Problem Description
It was reported that after the nasogastric (ng) tube was placed, the patient went home and the ng tube became dislodged the day after.The patient allegedly went back to the hospital to have an additional surgery to replace the ng tube.The attending physician believed that the portion of the balloon where there was glue seemed as if it had peeled off and flipped on itself; deflating the balloon and causing it to fall out.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE
• Common Device Name: NG TUBE
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6526861
• Report Number: 1018233-2017-02149
• Device Sequence Number: 1627844
• Product Code: BSS
• UDI-Device Identifier: 00801741052262
• UDI-Public: (01)00801741052262(10)NGAW1092
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0042160
• Device Lot Number: NGAW1092
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention