MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY NBR 20 FR; FEEDING TUBE

Model Number	000702
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was not provided, therefore, the device history records could not be reviewed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that some time post gastrostomy feeding tube placement, an alleged leak was identified from the cap of the feeding adapter.Reportedly, feeding adapter was removed and another feeding adapter was placed.There was no reported patient injury.
Event or Problem Description
It was reported that some time post gastrostomy feeding tube placement, an alleged leak was identified from the cap of the feeding adapter.Reportedly, feeding adapter was removed and another feeding adapter was placed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, a dhr review, and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one feeding tube adapter was returned for evaluation.Both caps were returned sealed, product packaging and label were not returned.Sample appeared to have residue.Functional testing was performed.Microscopic visual observation and tactile evaluation were not performed.The investigation is in unconfirmed for fluid leak, as device was infused through both ports with water using a 10ml syringe and no leaks were noted.Although a definitive root cause could not be determined, improper fit between cap plug and port or improper fit between port and connections could have potentially caused or contributed to the reported event.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: g4 h11: 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.

• Brand Name: PONSKY NBR 20 FR
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9981303
• Report Number: 3006260740-2020-01444
• Device Sequence Number: 2953163
• Product Code: KNT
• UDI-Device Identifier: 00801741036293
• UDI-Public: (01)00801741036293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: 000702
• Device Catalogue Number: 000702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1