MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INTL PONSKY PULL PEG 20F; FEEDING TUBE

Model Number 010060

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided, a review of the device history records is not required as this is the only complaint with the provided lot#.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 11/2023).

Event Description

It was reported that prior to open the package of the gastrostomy feeding tube, an insect was allegedly found in the kit.Reportedly, another kit was used to perform the procedure.There was no patient contact.

Event Description

It was reported that prior to open the package of the gastrostomy feeding tube, an insect was allegedly found in the kit.Reportedly, another kit was used to perform the procedure.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was completed for the lot number.This is the first reported complaint for this lot number and this issue to date.Investigation summary: one unopened ponksy peg kit was returned for evaluation.Visual evaluation was performed, a foreign material was noted within the packaging.The investigation is confirmed and after investigation by the manufacturing site it was determined to be a manufacturing related root cause.Based on the visual evaluation of the sample, the complaint is confirmed.Per complaint description, the foreign material was detected by the customer and confirmed at division during the preliminary complaint-sample evaluation.According to the investigation performed, the most probable root cause is that the manufacturing operator inadvertently did not notice there was foreign material inside the package.This most likely occurred during the kitting / sealing process.Labeling: 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.H10: d4 (expiration date: 11/2023), g4.H11: h3, h6(results, 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.

• Brand Name: INTL PONSKY PULL PEG 20F
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9451421
• MDR Text Key: 170740522
• Report Number: 3006260740-2019-03805
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741081200
• UDI-Public: (01)00801741081200
• Combination Product (y/n): N
• PMA/PMN Number: K915841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 010060
• Device Catalogue Number: 010060
• Device Lot Number: HUCX2910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1