MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TAPE,COTTON POROUS,PREMIUM,1"X10YD

Catalog Number CUR290101

Device Problem Defective Device (2588)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the tape did not secure the veterinary patient's intravenous (iv) catheter as it was "not sticky." the iv catheter reportedly came out of the patient.A new iv catheter was inserted without further reported incident or adverse impact to the patient.The reporting facility indicated that this occurred with twelve (12) different veterinary patients, however, it could not be specified what type of animals were involved.Unused tape samples from the same product lot used in the incident were received and tested against a stock sample.It was observed that the adhesion aggression on the received sample performed marginally less than the stock sample and a slight difference in how tacky/sticky in the received sample was also noted.The returned sample was placed on human skin, rubber, paper, and plastic and it was noted that it did not hold up as securely as the stock sample.Although the reported product problem/issue was confirmed, the product is not intended to be utilized on non-human patients and use of the product in a veterinary environment may have led to the reported incident.Due to the reported need for medical intervention to replace the iv catheter, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the tape did not secure the veterinary patient's intravenous (iv) catheter.

• Type of Device: TAPE,COTTON POROUS,PREMIUM,1"X10YD
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 12362630
• MDR Text Key: 269394244
• Report Number: 1417592-2021-00147
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CUR290101
• Device Lot Number: 84321012202-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention