MAUDE Adverse Event Report: INTEGRA BURLINGTON MA, INC. NASHOLD BIOPSY NEEDLE (DISPOS)

Catalog Number NBND

Device Problems Out-Of-Box Failure (2311); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

This the first of 2 reports (same product id, same product problem, same facility, different occurrence).It was noticed that the internal sheath scraped against the outer sheath and the medical staff decided not to use the biopsy needle.The device was not in contact with the patient.Hence, there was no patient injury.

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

Additional information was received on march 18, 2015.On (b)(6) 2015, during the stereotactic biopsy on a (b)(6) year old male patient, it was noticed at the time of recovering the needle with the sample that the needle was scraping with the cannula it was more difficult to remove the needle, a higher difficulty than normal.The sample could be obtained properly.The inner sheath or outer sheath did not seem bent.The patient was already medicated with local anesthesia when the problem occurred.The distributor responded "in no event" when asked if there was any patient harm/injury, if there was a delay in surgery, or if there was any patient adverse consequence as a result of the delay.A replacement product was available to be used.Linked to mfg report number 1222895-2015-00010.

Manufacturer Narrative

Integra has completed their internal investigation 06/16/2015.Results: device history record reviewed for this product id lot # 0307857 manufactured on july 09, 2014 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr's, variances or rework.A two year lookback in trackwise for this reported failure and or related to "internal sheath scraped against the outer sheath" for this product id shows that 2 complaints were received including this case.Both complaints were reported on the same day by the same customer no new design or manufacturing trends have been identified this issue will be monitored.Conclusion: in summary - the device was not released for evaluation therefore the root cause to the end users experience could not be determined.This complaint will be reopened should we receive product.

• Brand Name: NASHOLD BIOPSY NEEDLE (DISPOS)
• Type of Device: NA
• Manufacturer (Section D): INTEGRA BURLINGTON MA, INC. ; burlington MA 01803
• Manufacturer Contact: rowena bunuan ; 6099362393
• MDR Report Key: 4594690
• MDR Text Key: 5463538
• Report Number: 1222895-2015-00011
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K032054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NBND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 74 YR