MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR SPETZLER LUMBAR-PERITONEAL SHUNT KIT, 80CM CATH; N/A

Catalog Number NL8507210

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A distributor reported that the two suture collars from the (b)(4) spetzler lumbar-peritoneal shunt kit were reported missing.On (b)(6) 2018, the scrub nurse observed the issue and it was reported that the device was not used.There was no patient contact and no patient injury.However, the event led to an increase in surgery time of around 30 minutes.The surgeon opened another product to complete the procedure.

Manufacturer Narrative

One (1) peritoneal shunt was received and a tuohy needle with sleeve.The following was observed by visual inspection: the unit components were not in their original package; therefore, the reported lot number could not be confirmed.Although two (2) suture collars were reported to be missing from the package, none of the three (3) suture collar or connector included in each package was present in the returned unit.The complaint cannot be confirmed since the unit was not in its original package.The root cause is undetermined,.

Manufacturer Narrative

No sample has been received for evaluation; thus, the complaint could not be confirmed.Device history records were verified: no anomalies were found.Quantities of suture collars served were verified against the quantity required and no discrepancy was noticed.No assignable cause associated to the manufacturing and/or packaging process of the product was identified on dhr review which could contribute to reported condition.No further evaluation is possible at this moment.

Event Description

N/a.

• Brand Name: SPETZLER LUMBAR-PERITONEAL SHUNT KIT, 80CM CATH
• 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
• MDR Report Key: 7701939
• MDR Text Key: 114427293
• Report Number: 2648988-2018-00036
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K811288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL8507210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1