MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 18F X 1.7CM BUTTON KIT; FEEDING AND DECOMPRESSION TUBES

Model Number	000282
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore a lot history review was performed.The device was not returned for evaluation.However, photos were provided for review.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 000282 feeding and decompression tubes allegedly experienced fluid leak.This report was received from one source.One patient was involved with no reported patient injury.The male patient age and weight were not provided.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was provided, therefore a lot history review was performed.The device was not returned for evaluation; however, photos were provided for review.The investigation is inconclusive for the fluid leak.A definitive root cause for the reported event could not be determined.The device is labeled for single use.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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 000282 feeding and decompression tubes allegedly experienced fluid leak.This report was received from one source.One patient was involved with no reported patient injury.The male patient age and weight were not provided.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was provided, therefore a lot history review was performed.The device was returned for evaluation; however, photos were provided and reviewed.The investigation is confirmed for the fluid leak and material rupture.A definitive root cause for the reported event could not be determined.The device is labeled for single use.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
This report summarizes one malfunction.A review of the reported information indicates that model 000282 feeding and decompression tubes allegedly experienced fluid leak and material rupture.This report was received from one source.One patient was involved with no reported patient injury.The male patient age and weight were not provided.

• Brand Name: 18F X 1.7CM BUTTON KIT
• Common Device Name: FEEDING AND DECOMPRESSION TUBES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791 ; * 00791
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10284316
• Report Number: 3006260740-2020-02472
• Device Sequence Number: 2679694
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2022

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
• Device Model Number: 000282
• Device Catalogue Number: 000282
• Device Lot Number: HUDP2234
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 12/31/2021
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/13/2020; 01/17/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown