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

Catalog Number	INS8401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that while the nurse was performing external ventricular drainage bag change, the leur lock on the accudrain with anti-reflux valve (ins8401) broke above the bag connection site.No patient injury or significant delay to treatment has been reported.There is indication that medical/surgical intervention was required.Additional information has been requested.
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
The accudrain with anti-reflux valve (ins8401) was returned for evaluation: device history record (dhr) - the device history record (dhr) was reviewed and no anomaly was observed that could be related to the reported condition.Failure analysis - the unit was visually inspected, and it was observed that the male luer lock that connects the large-bore stopcock to the 75cc burette was broken.Also, it was observed that a needleless port was attached to the patient-line stopcock.The stopcock had stress marks which is evidence of overtightening of the component.Therefore, the complaint is considered confirmed root cause - as per complaint evaluation, it is understood that the unit had been in use and that the ¿leur lock broke above bag connection site¿ when the drain bag was being changed/replaced.A possible root cause for the male luer lock breakage could be related to stressing the connection during drainbag changes.The luer to loosen the drainbag should be reached from the front of the stopcock and not from behind (between the backplate and the stopcock) since this would force the assembly forward.It was also observed that there was a needleless port attached to the patient-line stopcock and evidence of overtightening stress marks were observed at the stopcock connection.Therefore, a probable cause for the breakage could be related to product handling.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Two (2) units of accudrain with anti-reflux valve (ins8401) was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies were observed that could be related to the reported condition.Failure analysis: two (2) units returned, but only one (1) was originally documented.The lot number on both units were found to be 7380727 as reported in follow-up mdr #1.Unit #1 - the unit was visually inspected, and it was observed that the male luer lock that connects the large-bore stopcock to the 75cc burette was broken.Also, it was observed that a needleless port (non-integra) was attached to the patient-line stopcock.The stopcock had stress marks which is evidence of overtightening of the component.The luer lock that attaches to the drain bag was also revised: it was present and was tested by disconnecting and reconnecting the drain bag and the luer worked appropriately.Unit #2 - the unit was visually inspected, and it was observed that the luer lock that attaches the burette¿s large-bore stopcock to the drain bag was missing.No other defect was observed.It was noticed that a non-integra line-level and a needleless injection/sampling port were connected to the device.Therefore, the complaint is considered confirmed for broken device.Root cause: as per complaint evaluation, it is understood that the unit had been in use and that the ¿leur lock broke above bag connection site¿ when the drain bag was being changed/replaced.A possible root cause for the male luer lock breakage could be related to stressing the connection during drain bag changes.It was also observed that there was a needleless port attached to the patient-line stopcock and evidence of overtightening stress marks were observed at the stopcock connection.Unit #2 was broken in a different manner than unit #1, it was missing the luer lock that attaches the burette¿s large-bore stopcock to the drain bag.This most likely broke during drain bag change as described in the complaint report.This could be related to a stopcock/luer supplier defect, but based on the condition of unit #1, it could also be related to overtightening of the plastic luer lock.The observed breakages are of a different nature and thus do not lead to the conclusion that there is a product problem, also there was evidence of overtightening connections; hence, the most probable cause seems to be related to product handling.

• Brand Name: ACCUDRAIN WITH ANTI-REFLUX VALVE
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20452088
• Report Number: 2648988-2024-00039
• Device Sequence Number: 18296798
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2024

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: 04/30/2026
• Device Catalogue Number: INS8401
• Device Lot Number: 7380727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 12/09/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/02/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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