MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® PREMATURE INFANT FEEDING TUBE

Model Number	0036400
Medical Device Problem Codes	Restricted Flow rate (1248); Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that upon placing the feeding tube in the patient contrast did not flow through the tube.An attempt to flush the tube with saline was unsuccessful.No medical intervention was reported.
Event or Problem Description
It was reported that upon placing the feeding tube in the patient contrast did not flow through the tube.An attempt to flush the tube with saline was unsuccessful.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (with original packaging), ng feeding tube.Visual inspection of the sample noted no obvious visible defects.The tube was attempted to be flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water), and the solution failed to advance through the tube (flow rate = 0).This is out of specification per inspection procedure which states, "the flow must be equal or greater." the tubing was unable to be removed from the funnel for closer investigation.Scissors were used to puncture the lumen, and the solution immediately drained from the device.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿blocked due to tube feedings, meds, inaccurate procedure.¿ 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: "single use.This is a single use device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device do not resterilize.Failure, and/or lead to injury, illness or death of the patient.Do not use if package is damaged.Authorized representative in the european community manufacturer contains or presence of phthalates: di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks." h11:section a through f - the information provided by bd 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 bd.
Additional Manufacturer Narrative
The reported event could not be confirmed.The device was not returned for evaluation.A potential failure mode could be ¿enfit hub does not prevent medical device misconnections to feeding tubes¿ with a potential root cause of ¿dimensions not designed correctly; poor material selection¿.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: ¿premature infant feeding tube plastic, 5 fr., 1/16¿ (1.7mm), 15¿ (38cm) length 1cm depth markings x-ray opaque stripe" section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that upon placing the feeding tube in the patient contrast did not flow through the tube.An attempt to flush the tube with saline was unsuccessful.No medical intervention was reported.

• Brand Name: BARD® PREMATURE INFANT FEEDING TUBE
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9954585
• Report Number: 1018233-2020-02550
• Device Sequence Number: 14278642
• Product Code: FPD
• UDI-Device Identifier: 00801741034404
• UDI-Public: (01)00801741034404
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2020

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: 01/24/2024
• Device Model Number: 0036400
• Device Catalogue Number: 0036400
• Device Lot Number: NGDN1764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 04/20/2020; 05/21/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 04/24/2020; 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1