MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM+; POUCH, COLOSTOMY

Model Number 416740

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

Event Description

The end user's caregiver reported the starter hole of twenty appliances was off centered.Additionally, caregiver stated that five pouches from the box were worn and had fifteen more were off centered but not worn, from two market units with same lot.Additionally, it was also mentioned that end user had noticed several weeks ago that the pouches were not sticking to her skin, and she had not changed any part of her application routine.Also, her wear time was reduced from three days to less than one day, and she denied any leakage of stool.No photo is available at this time.

Event Description

Pr (b)(4).Update - additional information received material#:309653 batch#:3208287 it was reported by customer that they have noted that on some of the bd 50ml syringes ndc 08290-3096-80 that the printing of the lines and numbers are missing in spots and they have had to throw them away.Today they threw out at least 30 and they all had the same lot # which is 3208287 exp date 6/30/2028.They have not used any of the syringes that were noted to have missing lines ore numbers, but wanted to report this to bd.Verbatim: customer stated that we have noted that on some of the bd 50ml syringes ndc 08290-3096-80 that the printing of the lines and numbers are missing in spots and we have had to throw them away.Today we threw out at least 30 and they all had the same lot # which is 3208287 exp date 6/30/2028.We have not used any of the syringes that were noted to have missing lines ore numbers, but wanted to report this to your company so you can be aware.Additional info from customer: -what is the total quantity of products found defective? ~30 -is there any adverse event or serious injury occurred? no -what is the event date? 10/12/2023 -are you able to provide sample to bd for investigation? if no, can a photo be provided? if yes, please provide mailing address.Products were disposed of prior to staff telling me.I can not provide a sample or photo.

Manufacturer Narrative

Pr (b)(4) follow up report it was reported by the consumer the syringes are missing printing lines and numbers.As a sample was not returned, a thorough sample investigation could not be completed.A device history record review was completed for provided material number 309653, lot 3208287.There was documentation of this type of defect during the production run of this lot.A quality notification was issued for the scale marking issue.It could be possible the customer received escapes from this incident experienced during production.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.H3 other text : see h10 narrative.

• Brand Name: ESTEEM+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 16251801
• MDR Text Key: 308543578
• Report Number: 9618003-2023-00173
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455188499
• UDI-Public: 00768455188499
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416740
• Device Lot Number: 1K04031J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female