MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD BUTTON GASTROSTOMY TUBE, KIT, 24F; FEEDING DEVICE

Model Number	000285
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation; however, photos have been provided.The investigation of the reported event is currently underway.(expiry date: 07/2022).Device not returned.
Event or Problem Description
It was reported that sometime post feeding tube placement, the device allegedly had leak of diet.It was further reported that the feeding device was replaced.There was no reported patient injury.
Event or Problem Description
It was reported that seven days post feeding tube placement, the device allegedly had leak.It was further reported that the feeding device was replaced.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the sample was not returned for evaluation, three electronic photos were provided for review.The investigation is confirmed for the reported fluid leak, issue as diet was found leaking from or around the device in the provided photos.Based upon the available information a definitive root cause could not be determined.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: d4 (expiry date: 07/2022), g3.H11: b3, 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.H3 other text : device not returned.

• Brand Name: BARD BUTTON GASTROSTOMY TUBE, KIT, 24F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10746542
• Report Number: 3006260740-2020-20257
• Device Sequence Number: 4086884
• Product Code: KGC
• UDI-Device Identifier: 10801741087889
• UDI-Public: (01)10801741087889
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K904779
• 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): 05/17/2021

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: 000285
• Device Catalogue Number: 000285
• Device Lot Number: HUDU2369
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other