MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUAL PORT FEEDING ADAPTER 20F; MISC. FEEDING PRODUCTS

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the patient complained of loose cap and leakage from the adaptor.The health professional confirmed that the cap of adaptor was loose.The adaptor had been used since (b)(6) 2017.No reported patient harm.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred per 21 crf803.19.
Event or Problem Description
It was reported that the patient complained of loose cap and leakage from the adaptor.The health professional confirmed that the cap of adaptor was loose.The adaptor had been used since (b)(6) 2017.No reported patient harm.

• Brand Name: DUAL PORT FEEDING ADAPTER 20F
• Common Device Name: MISC. FEEDING PRODUCTS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6546170
• Report Number: 3006260740-2017-00576
• Device Sequence Number: 13650372
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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: N/A
• Device Catalogue Number: 000333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1