MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH ENFIT¿; NASOGASTRIC TUBE

Model Number	EN0042160
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that provider attempted to place a nasogastric tube (ng tube) (the new enfit style that we have just started to carry) 16fr or 18fr and had the first 3 nasogastric tubes clog (batch# nggr2656) , was successful on the 4th tube.Per follow-up via email on 10may2023, it was reported that the new bd enfit compatible sump tubes had an enfit tip on them which required a suction adapter to perform suction.The port and adapter had a narrow channel and bronson clinicians had reported clogging issues (batch# ngfw1855).
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that provider attempted to place a nasogastric tube (ng tube) (the new enfit style that we have just started to carry) 16fr or 18fr and had the first 3 nasogastric tubes clog (batch# nggr2656) , was successful on the 4th tube.Per follow-up via email on 10may2023, it was reported that the new bd enfit compatible sump tubes had an enfit tip on them which required a suction adapter to perform suction.The port and adapter had a narrow channel and bronson clinicians had reported clogging issues (batch# ngfw1855).Per follow up via phone on 02jun2023, customer has issues with two lots nngy3160and nngv4485.The customer has a sample to send in and the only patient impact was that catheters had to be re-inserted, but no harm to any patients.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "dimensions not designed correctly".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "indications for use: bard® nasogastric sump tubes with enfit¿ connector are intended to be used for: ¿ decompression of stomach by suction or aspiration of gastric contents.¿ short-term administration of term tube feeding, lavage fluid and medications.Contraindications: ¿ patients with known tape or adhesive allergies.Warnings 1.Use with caution in patients with a history of head trauma, facial trauma, esophageal diseases and patients with potential for vomiting.2.Do not force nasogastric tube during insertions; damage to the nasal passage and mucosa and bleeding may occur.3.Measure insertion length carefully- excessive insertion length of tube into the stomach may lead to coiling and/or formation of tube-knot.4.Lubricate the tube generously with water soluble lubricant prior to insertion.Do not use petroleum-based products as they may be harmful to the respiratory tract.5.Reflux of gastric contents into the blue vent lumen indicates that the suction lumen is obstructed or suction is too low.Routinely check for reflux in the blue vent lumen and clear as per applicable directions.Failure to clear the obstruction or clear prevent® filter may cause gas & fluid buildup in stomach, aspiration of gastric contents, aspiration pneumonia and other complications.6.Do not inject fluid through the prevent® filter as this may result in blockage and leakage of filter.7.Monitor patient for nasal erosion, sinusitis, esophagitis, esophagotracheal fistula, gastric erosion and pulmonary & oral infections." corrections: e h11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH ENFIT¿
• Common Device Name: NASOGASTRIC TUBE
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17020614
• Report Number: 1018233-2023-03875
• Device Sequence Number: 6343383
• Product Code: BSS
• UDI-Device Identifier: 00801741113802
• UDI-Public: (01)00801741113802
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 09/30/2026
• Device Model Number: EN0042160
• Device Catalogue Number: EN0042160
• Device Lot Number: NGFW1855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown