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

Patient age/date of birth: mean ± sd was 68.1 ± 11.0.Patient gender: 56.4% male, 43.6% female.Additional patient information unknown/not provided.Date of event: exact dates not provided.Article acceptance date is 01 august 2022.The study was conducted for surgeries performed between november 2017 and may 2020.Model number: complete model number is unknown, as the serial number was not provided.Catalog number: complete catalog number is unknown, as the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as the serial number was not provided.Udi number: unknown, as the serial number was not provided.Implant date: unknown/ not provided.Explant date: n/a, as lens remains implanted.Device manufacture date: unknown, as the serial number was not provided.Device evaluation: product testing could not be performed because the product was not returned (the lens remains implanted).Therefore, a failure analysis of the complaint device cannot be completed, and the reported event cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed, and complaint history were not reviewed since the serial number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Citation: sheen-ophir, s.; reitblat, o.; levy, a.; assia, e.I.; kleinmann, g; deviation from the planned axis of three toric intraocular lenses; published online 12th august 2022; https://doi.Org/10.1038/s41598-022-17811-x.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Hold vm 3.2 it was reported by teleflex: device does not stick to the skin "it was reported that: dressing with ineffective attachment to the patient's skin.So the piccline self-removed on the length of 20cm when the patient stood up in his chair.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: 16463797
• MDR Text Key: 310828424
• Report Number: 2182318-2023-00010
• 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