MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUAL PORT FEEDING ADAPTER 20F; 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
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that every time the device is used the cap (small) comes of easily.Tape was used to secure the cap.There was no reported patient injury.
Event or Problem Description
It was reported that every time the device is used the cap (small) comes of easily.Tape was used to secure the cap.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a lot history review, a dhr review, and complete manufacturing review could not be conducted as the lot number was not returned.Investigation summary: one feeding tube bifurcation adaptor was returned for evaluation.Functional, visual, microscopic, and dimensional evaluations were performed.The investigation is unconfirmed for a loose medicine (small) port cap as when backpressure was applied to the sample, this cap did not dislodge easily.No leaks were noted on the small port.The small port inner diameter and cap outer diameter were within specification.The large port id being out of specification was addressed in separate complaint.No definitive root cause could be determined as the complaint was unconfirmed.However, possible causes of such an event may include insufficient insertion of the port plug, excessive force on the plug during insertion, and wear/deformation over time.Labeling 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.

• Brand Name: DUAL PORT FEEDING ADAPTER 20F
• 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: 7712229
• Report Number: 3006260740-2018-01805
• Device Sequence Number: 16341042
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 06/29/2018
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1