MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUAL PORT FEEDING ADAPTER 20F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000333
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
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 has been returned 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 after approximately one week, the cap on the device broke.The device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one ponsky dual-port feeding adaptor was returned for evaluation.The proximal cap was noted to be detached.When viewed under magnification, the break surface of the strap was noted to be jagged.Based on these findings, the investigation is confirmed for the reported cap detachment.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Potential contributing factors include material fatigue, tight fit around plug and tension on the strap/cap.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that after approximately one week, the cap on the device broke.The device was removed and replaced.There was no reported patient injury.

• 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: 7782401
• Report Number: 3006260740-2018-02061
• Device Sequence Number: 1204407
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2019

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: 08/08/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 02/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1