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

Model Number	006035
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
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.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.
Event or Problem Description
It was reported that the depth marks on the catheter shaft had allegedly disappeared.There was no reported patient injury.
Additional Manufacturer Narrative
It was also identified that the fda rn number was incorrect and the correct fda rn number (b)(4).This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.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.Investigation summary: one nbr ponsky feeding tube was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for missing/worn depth marks, as the sample was returned with worn markings near the distal end of the device and no other markings were observed on the device.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.Potential contributing factors include cleaning with incompatible solvents and excessive rubbing.
Event or Problem Description
It was reported that the depth marks on the catheter shaft had allegedly disappeared.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: 7500678
• Report Number: 2020394-2018-00625
• Device Sequence Number: 112949
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: 05/10/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 02/02/2019
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1