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

Model Number 006035

Device Problems Break (1069); Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 08/03/2016

Event Type  malfunction  

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 Description

It was reported that the catheter was found discolored (black) after removal.The catheter was implanted at another facility.No other information was reported.On (b)(6) 2017 broken main port plug strap was found during evaluation.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the report of a broken main port plug strap is confirmed, and the cause is determined to be likely use-related.The complaint of discoloration was confirmed, in the form of black deposited material found in the lumen of the catheter.The pieces of the device appeared to fit together reasonably well, though the deposited material interfered with the fit.Microscopic evaluation found the main port plug strap to be broken near the port.The break, under magnification, appeared highly irregular and uneven.The main port plug strap was found to be broken near the port.The break was irregular.The tape was taken off to find that the small port and strap appeared free of mechanical damage.The cause of the broken strap appears to be related to excessive manipulation during use.

Event Description

It was reported that the catheter was found discolored (black) after removal.The catheter was implanted at another facility.No other information was reported.Update on 07/07/2017 - broken main port plug strap was found during evaluation.

• Brand Name: PONSKY PEG SAFETY SYSTEM - "PULL"
• Type of Device: TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6746439
• MDR Text Key: 81328690
• Report Number: 3006260740-2017-01139
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741081187
• UDI-Public: (01)00801741081187
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K915841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006035
• Device Catalogue Number: 006035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1