MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY PEG SAFETY SYSTEM - "PULL" (20F); TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	006035
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
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 is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that nutrition leakage occurred from the middle of the catheter after the constructed gastrostomy.The damaged part of catheter was cut off.The remaining piece of the catheter is currently in use.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a lot review was not performed sine no lot number was provided by the complainant.Investigation summary: one partial segment of peg safety 20 fr pull was returned for evaluation.Functional, visual, tactile and microscopic evaluations were performed.The investigation is confirmed for fluid leak, as the product had an s-shaped, circumferential crack was observed approximately 1.2 cm from one of the ends of the catheter.Also, the port was infused with a 12ml syringe and was patent to infusion and aspiration.When infused against resistance, a leak was observed at the crack.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that nutrition leakage occurred from the middle of the catheter after the constructed gastrostomy.The damaged part of catheter was cut off.The remaining piece of the catheter is currently in use.There was no reported patient injury.

• Brand Name: PONSKY PEG SAFETY SYSTEM - "PULL" (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: 7997492
• Report Number: 3006260740-2018-02989
• Device Sequence Number: 13896793
• Product Code: KNT
• UDI-Device Identifier: 00801741081187
• UDI-Public: (01)00801741081187
• 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): 03/18/2019

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: 006035
• Device Catalogue Number: 006035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1