MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED

Catalog Number 203001

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

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

It was reported that the physician drew up 3ml of the 203001 duraseal spine ous but only 1ml was able to be used on (b)(6) 2019.The product did not have the full 3ml in the syringe.The device was in contact with the (b)(6) year old patient but there was no patient injury reported.It was unknown if the event led to an increase in surgery time.The staff used another unit.

Manufacturer Narrative

The product has not been returned for evaluation.A failure analysis and determination of root cause is not possible due to product was not returned.The reported complaint is unconfirmed.

Manufacturer Narrative

Duragen (203001) was returned for evaluation: failure analysis - the duragen sample received back had 1 tray containing 1 y-connector, 3 spray tips, 1 syringe holder and 1 plunger cap, 2 syringes (1 blue syringe and 1 clear syringe), and 1 vial.The y-connector, 3 spray tips, 1 syringe holder, and 1 plunger cap were all found clean with no traces of blue solution.The clear syringe was returned with 1.5 ml of solution, no signs of use were observed.The blue syringe was returned empty with traces of dry solution close to the tip.The vial was returned with the bioset fully depressed, no red line was visible.Traces of blue solution were observed on top of the bioset and inside the vial.Following sample evaluation, the reported failure mode could not be confirmed because the blue syringe was observed empty with dry solution inside and the vial was observed with traces of blue solution, meaning the peg had been reconstituted.The content of each syringe should be 1.5 ml; with the blue syringe returned empty, the volume of the blue syringe could not be confirmed.Root cause -the root cause is undetermined and the complaint was unable to be confirmed with the information available.A dhr review and trending were performed as part of the evaluation.Proper finished good testing was performed prior to release as indicated in the dhr.Product was received was tested and no issues where found nor could the complaint be replicated.Per the dfmea, potential causes of failure include: performance, adhesion barrier.The risk remains acceptable per the risk analysis.

• Brand Name: DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 9249943
• MDR Text Key: 205356732
• Report Number: 3003418325-2019-00032
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 203001
• Device Lot Number: 60162337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2018
• 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 Age: 70 YR