MAUDE Adverse Event Report: COVIDIEN ONE BOTTLE TUBING SET; BOTTLE, COLLECTION, VACUUM

Model Number 8884729500

Device Problem Material Twisted/Bent (2981)

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

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that there was a single and double crease (bent) on the tube.The bent is firm and prevents flow of the liquid in the device.The issue was discovered before use.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The customer has provided a picture for the evaluation.Upon picture analysis, the reported condition is confirmed.The most likely root cause could be due to the coiling process that is complete prior to wrapping in blue wrap, in that the tube is either coiled too tight or coiled too close to the dip tube.A previous communication was held with the manufacturing team and a quality alert was issued in relation to customer complaint for kinks in tubing for this family, the lot number for this complaint (b)(4) was manufactured prior to this communication session.We will keep monitoring the process for any adverse trends that require immediate attention.A corrective action is not applicable at this time.

• Brand Name: ONE BOTTLE TUBING SET
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 11081133
• MDR Text Key: 225327264
• Report Number: 9611018-2020-00471
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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
• Device Operator: No Information
• Device Model Number: 8884729500
• Device Catalogue Number: 8884729500
• Device Lot Number: 18I238FHX
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 03/18/2021
• Patient Sequence Number: 1