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

Model Number	0036400
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	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.
Event or Problem Description
It was reported that the feeding tube was labeled wrong, and the tube was too thick.The customer noted that half the box was correct and half was not.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿burnt mold¿ with a potential root cause of ¿double feeding in molding machine¿.The lot number is unknown; therefore, the device history record could not be reviewed.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the feeding tube was labeled wrong, and the tube was too thick.The customer noted that half the box was correct and half was not.

• 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: 9732711
• Report Number: 1018233-2020-01181
• Device Sequence Number: 19551266
• Product Code: FPD
• UDI-Device Identifier: 00801741034404
• UDI-Public: (01)00801741034404
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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 Model Number: 0036400
• Device Catalogue Number: 0036400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1