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

Model Number	0036400
Medical Device Problem Code	Misassembled (1398)
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 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 was not returned.
Event or Problem Description
It was reported that a patient had been struggling with breastfeeding her baby, attempting multiple times during a nurse's shift.The patient had been set up with a nipple shield, feeding tube and syringe to assist her in feeding her newborn.After multiple attempts to feed the newborn, it was noticed that the newborn was still unable to intake the supplemental formula from the feeding tube and syringe.Upon further inspection of the feeding tube, the nurse noticed that the tube had only one hole at the end of it instead of two.The infant was not able to suck the supplemental formula from the device.Per additional information: the mother was trying to breastfeed and use the device at the same time.
Additional Manufacturer Narrative
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 state the following: "premature infant feeding tube plastic, 5 fr., 1/16¿ (1.7mm), 15¿ (38cm) length 1cm depth markings x-ray opaque stripe 0036400 0036420 premature infant feeding tube plastic, 5 fr., 1/16¿ (1.7mm), 36¿ (91cm) length marking 8¿ (20cm) from proximal end x-ray opaque stripe adult/pediatric feeding tube plastic, 8 fr., 3/32¿ (2.7mm) 42¿ (107cm) length marking dimensions from proximal end first mark 10¿ (25cm), second mark 20¿ (51cm), third mark 30¿ (76cm) x-ray opaque stripe 0036430 infant feeding tube plastic, 8 fr., 3/32¿ (2.7mm), 15¿ (38cm) length 1cm depth markings x-ray opaque stripe 0036410 sterilized using ethylene oxide.Bard® feeding tubes 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 failure, and/or lead to injury, illness or death of the patient.Do not resterilize.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.".
Event or Problem Description
It was reported that a patient had been struggling with breastfeeding her baby, attempting multiple times during a nurse's shift.The patient had been set up with a nipple shield, feeding tube and syringe to assist her in feeding her newborn.After multiple attempts to feed the newborn, it was noticed that the newborn was still unable to intake the supplemental formula from the feeding tube and syringe.Upon further inspection of the feeding tube, the nurse noticed that the tube had only one hole at the end of it instead of two.The infant was not able to suck the supplemental formula from the device.Per additional information: the mother was trying to breastfeed and use the device at the same time.

• 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: 7350173
• Report Number: 1018233-2018-00863
• Device Sequence Number: 16579591
• Product Code: FPD
• UDI-Device Identifier: 00801741034404
• UDI-Public: (01)00801741034404
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: 11/18/2021
• Device Model Number: 0036400
• Device Catalogue Number: 0036400
• Device Lot Number: NGBR3192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1