MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE; N/A

Catalog Number SP0214

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 08/22/2017

Event Type  Injury  

Event Description

The stopcock at the proximal end of the tubing closest to the patient was either pulled out or fell out.Cerebrospinal fluid (csf) leaked out onto the pillow and air was introduced into the brain.It was reported that the patient will most likely require a shunt.Additional information has been requested.

Manufacturer Narrative

Investigation completed 11/17/2017.Complaint information did not identify a lot number, but lot number 1170024 was obtained from the returned unit¿s label.No manufacturing event or rework was identified related to this lot.Manufacturing (pack) date: january 19, 2017.Expiration date: december 31, 2018.Review of complaint system from (b)(6) 2015 to (b)(6) 2015 found that there are no previous cases in the two (2) year period reviewed in which the stopcock¿s plug had fallen off.The complaint occurrence rate for this type of incident is then (b)(4).Returned unit had all the device¿s components except the white plug from the patient line¿s stopcock.A transducer was found still attached to the zero-reference stopcock.The zero-reference stopcock was also inspected since it is the same part number (200407-001) as the one used in the patient line.No defects were observed in the zero-reference stopcock.The patient line stopcock was inspected and besides missing the white plug, there was no other defect detected (i.E., cracks or observable deformity).No evidence of manufacturing error was found that could have caused the reported condition.There are controls in place to detect components failure.The root cause could be related to product handling, but cannot be confirmed; therefore, the root cause for this event is considered unknown.

Manufacturer Narrative

Additional information received on 05sep2017 and 14sep2017: it was reported that on (b)(6) 2017, the (b)(6) patient, who had a ventriculostomy in place, was compliant and in the angio suite.At no time did the patient move in such a way as to tug on the drain.The nurse went down to pick up the patient post procedure and it was noted that the pillow was wet.It was unknown how much csf leaked.On further inspection, it was noted that the stopcock most proximal to the patient had come completely out of place and spinal fluid was dipping out.There were no signs of trauma to the tubing and cracks noted.The white stopcock was missing completely.It was unknown how long the device was not connected and exposed to air.Neurosurgery was notified.A new drain was placed.The attending was notified and wanted the drain removed immediately.The patient was then started on triple antibiotics.The customer stated that they have not heard of any other adverse outcome.The lot number of the device was unknown.Linked to uf/ importer report # (b)(4).

• Brand Name: INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE
• 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 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6853718
• MDR Text Key: 85574902
• Report Number: 2648988-2017-00032
• Device Sequence Number: 1
• Product Code: JXG
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP0214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 09/05/2017; 11/17/2017
• Supplement Dates FDA Received: 09/22/2017; 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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 Outcome(s): Other
• Patient Age: 57 YR