MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUAL PORT FEEDING; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000333
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported during evaluation of the returned sample, the primary port was allegedly found to be out of specification.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a dhr review was not performed as the lot number was not provided by the complainant.Investigation review: one feeding tube bifurcation adaptor was returned for evaluation.Functional, visual, microscopic, and dimensional evaluations were performed.The investigation is confirmed for an out of specification large port and cap as the large port cap od measured lower than specification and the large port id measured larger than specification.In addition, the feeding adaptor was patent to infusion and aspiration but leaks were observed with low hydraulic back pressure and the larger cap dislodged relatively easily.Although a definitive root cause could not be determined, wear from regular use without replacement according to ifu instructions or improper dimensions as manufactured could have potentially caused or contributed to the reported event.The ifu states ¿routinely inspect the dual port feeding adaptor for secure safety cap closure and replace as necessary.If the safety cap does not close securely, there is an increased potential for leakage of gastric contents which could lead to skin irritation and/or infection.¿ functional, visual, and dimensional evaluations were performed at division.During functional testing, leaks were observed with low hydraulic back pressure and the larger cap dislodged relatively easily.Dimensional evaluation disclosed that the large cap od was slightly below specification by -0.010¿.On the other hand, the measured diameter on the large cap port id was slightly above specification by +0.001¿.Based on the sample evaluation results, the reported complaint can be concluded as confirmed.However, a definite root cause could not be determined (cause unknown).Although the measured diameters exceeded their respective specification, it must be noted that this was a used sample, which a repetitive use could somewhat affect the original dimensions due to material fatigue / wear.Therefore, these results do not necessarily reflect the original state of this component.Furthermore, this complaint was opened as a result of the evaluation performed on this returned sample corresponding to complaints #(b)(4) (which responds to the original complaint on an alleged main (large) port cap break issue) and #(b)(4) (which was opened to respond to the secondary alleged issue of a loose secondary (small) port cap).The customer never reported a complaint related to fitting issues (e.G.Loose cap or leakage) with the main (large) port cap.Label review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: g4 h11: h3, h6(result, conclusion) 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.
Event or Problem Description
It was reported during evaluation of the returned sample, the primary port was allegedly found to be out of specification.There was no reported patient injury.

• Brand Name: DUAL PORT FEEDING
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8604254
• Report Number: 3006260740-2019-01362
• Device Sequence Number: 2349450
• Product Code: KNT
• UDI-Device Identifier: 10801741080934
• UDI-Public: (01)10801741080934
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 000333
• Device Catalogue Number: 000333
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1