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

Catalog Number	INS8401
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the accudrain with anti-reflux valve (ins8401) was placed on (b)(6) 2024 and was found to be clogged on (b)(6) 2024.As a result, the accudrain was rinsed and changed on (b)(6) 2024.No information has been provided on patient outcome.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields.Accudrain with anti-reflux valve (ins8401) was not returned, and no photo was provided that could clarify the cause of the reported blockage.Therefore, a verification cannot be made to determine a possible root cause.It is noted that the device was implanted on (b)(6)2024 and was reported clogged on (b)(6)2024; therefore, the unit worked for 8 consecutive days without any issues.It was also reported that the neurosurgeon associate was able to unclog the device and continued using it until (b)(6) 2024.This supports that the reported condition is not related to a device malfunction.In addition, the customer reported three (3) separate complaints (this one included) related to clogged units involving two (2) different lots (7403915 and 7403931); however, there are no other complaints for the reported lots aside from these ones.Lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.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.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The accudrain with anti-reflux valve (ins8401) was subsequently returned: failure analysis - the unit was received with other items which are not part of accudrain.On the zero-reference stopcock, there was a line attached with two (2) transducers assembled in line with two (2) baxter saline solution bags attached to the transducer.Also, there were two (2) foreign white stopcocks: one (1) on the burette¿s stopcock (the drain bag was not returned) and the other on the patient line stopcock.The assembly attached to the zero-reference stopcock was removed and water was passed through the stopcock and water flowed freely in all three (3) possible stopcock open positions.The same was done with the patient line stopcock with the same result, and the burette stopcock was opened and the burette drained.To verify all returned items, the non-integra lines and transducers were verified and no occlusion was detected.Therefore, the complaint is considered unconfirmed.Root cause - it is noted that the device was implanted on (b)(6) 2024, and was reported clogged on (b)(6) 2024; therefore, the unit worked for 8 consecutive days without any issues.It was also reported that the neurosurgeon associate was able to unclog the device and continued using it until (b)(6) 2024.This supports that the reported condition is not related to a device malfunction.In addition, the customer reported three (3) separate complaints (this one included) related to clogged units involving two (2) different lots (7403915 and 7403931); however, there are no other complaints for the reported lots aside from these ones.Based on the foregoing, a probable root cause has been identified in the product ifu¿s ¿complications¿ section as follows: ¿obstruction, partial obstruction, or irregular flow, may occur.Causes may include (but not limited to) obstruction by particulate matter (blood clots, fibrin, brain fragments), or mal-positioning of the ventricular catheter." no further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: ACCUDRAIN WITH ANTI-REFLUX VALVE
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20803221
• Report Number: 2648988-2024-00044
• Device Sequence Number: 9391966
• Product Code: JXG
• UDI-Device Identifier: 10381780023883
• UDI-Public: 10381780023883
• Combination Product (Y/N): N
• PMA/510(K) Number: K042825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: INS8401
• Device Lot Number: 7403915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 01/24/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/21/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown