MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITH ANTI-REFLUX VALVE; N/A

Catalog Number INS8401

Device Problem Break (1069)

Patient Problem Bacterial Infection (1735)

Event Date 02/20/2024

Event Type  Injury  

Event Description

A facility reported that a pediatric patient had an accudrain (ins8401) since february 8, 2024, and had been on the medtronic duet prior to that.The luer lock near the bag fell off during bag replacement yesterday, and a new accudrain was placed.No patient injury has been reported; however, the patient had a positive cerebrospinal fluid (csf) culture.The drain was placed bedside in the picu and is not available as it was discarded.Additional information received from integra representative indicates the following: -the drain was purchased in february and then placed on the patient as soon as in-service was done on 2/8/2024.-the drain broke, and the reporting integra representative was informed on 2/20/2024.It was on the patient for quite some time.-the staff is used to a medtronic drain which has a luer lock that tightens the opposite direction from our accudrain (in relation to the drainage bag replacement).It is possible it weakened from multiple attempts to loosen it (but in the wrong direction).-the bag was replaced approximately every other day.

Manufacturer Narrative

Accudrain with anti-reflux valve (ins8401) was not returned for evaluation as the product was discarded at the facility, and lot number information has not been provided; therefore, device history record (dhr) could not be reviewed.A photo was provided to show where the device broke; however, the photo provided corresponds to a sample device and not to the reported broken device.Therefore, the complaint is considered unconfirmed.According to the information provided, the patient had the accudrain since february 8th, 202, and a different device (medtronic duet) was previously used on the patient.The complaint narrative states that due to a recall of the medtronic device previously used on the patient, the hospital (kaiser) ordered the accudrain.The reporter indicated that they had a discussion with the rn to make sure they tighten and loosen the luer lock in the correct direction, which may be opposite to how a previous device is loosened.Therefore, based on the available information, the most probable root cause for this event is related to user error since the nurses were used to a different device and the way the luer lock tightens and loosens in the accudrain may be opposite to the previous device.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: ACCUDRAIN WITH ANTI-REFLUX VALVE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18960111
• MDR Text Key: 338371180
• Report Number: 2648988-2024-00009
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780023883
• UDI-Public: 10381780023883
• Combination Product (y/n): N
• PMA/PMN Number: K042825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS8401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female