MAUDE Adverse Event Report: TIDI PRODUCTS LLC TELEFLEX GRIP-LOK SPECIALTY SECUREMENT DEVICE, CVC & PICC; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number 3604MCS-TA-1

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Manufacturer Narrative

The complaint product was not available for evaluation.Retain samples from 3 of the last 4 lots shipped to this customer were evaluated.Multiple retain samples were tested for each of the 3 lots pulled for adhesive functionality via hanging weight test.All reviewed samples passed the test and functioned per original release specifications.Additionally, the samples were applied to the tester¿s skin to see if they would stick to the skin and all did.The reported complaint could not be duplicated.The reporter was contacted for more information regarding the event and the users and it was reported that they are new users who are using the grip-loks because of a shortage of the previously used device: piccline statlock ref: (b)(4) bd.Similar complaints have been reported from former stat-lok users due to the aggressive adhesive used in that device.The reporter (distributor) was asked if any training had been provided to the end user or if training is planned, but no response was received.At this time, it appears that the root cause is related to new users and device training problem.The reporter has been provided with a copy of the current instructions for use to be forwarded to the customer as necessary.No further corrective or preventive actions are required currently.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file (b)(4).

Event Description

It was reported by teleflex: not holding / device does not stick to the skin: "this complaint covers the complaint with no details.Dressing with ineffective attachment to the patient's skin.All the lot numbers are involved.¿.

• Brand Name: TELEFLEX GRIP-LOK SPECIALTY SECUREMENT DEVICE, CVC & PICC
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16463807
• MDR Text Key: 310529849
• Report Number: 2182318-2023-00011
• Device Sequence Number: 1
• Product Code: KMK
• UDI-Device Identifier: 00618125160945
• UDI-Public: 00618125160945
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2023

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 Model Number: 3604MCS-TA-1
• Device Catalogue Number: 3604MCS-TA-1
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1