MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TAPE,TRANSPARENT,CURAD,1"X10YD,LF,120/CS

Catalog Number NON270201

Device Problem Mechanical Problem (1384)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/28/2022

Event Type  Injury  

Event Description

According to the facility between (b)(6) 2022 -present the securement tape comes lose causing the preterm babies to be restuck'.

Manufacturer Narrative

According to the facility between '(b)(6) 2022-present the securement tape comes lose causing the preterm babies to be restuck'.Per the facility the access sites are 'secured with multiple pieces of tape and the sites are checked hourly'.Per the facility the tape is not exposed to liquid or water, however, they stated that the 'babies move around which leads them to having to replace the whole dressing causing a risk of losing the iv'.The facility stated that they've had to replace iv sites due to the tape coming lose.Per the facility the impacted patients are reporting to be fine.The sample was returned for evaluation, but a definitive root cause could not be determined.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: TAPE,TRANSPARENT,CURAD,1"X10YD,LF,120/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 16195919
• MDR Text Key: 307604384
• Report Number: 1417592-2023-00026
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NON270201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other