MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ NEEDLE BNS TUOHY OPEN SHLD; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405482

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

H.Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for incorrect needle length with the incident lot was observed.A review of the device history record was completed for the incident lots and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer samples, bd was able to confirm the customer¿s indicated failure mode for incorrect needle length.However, the confirmed customer indicated failure mode specification is not a release criteria.Root cause description: based on the investigation, possible root cause(s) may be related to the manufacturing process at the supplier store.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bevel length of the needle on the bd¿ needle bns tuohy open "shld" was longer than the master sample.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that the bevel length of the needle on the bd needle bns tuohy open shld was longer than the master sample.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.

• Brand Name: BD¿ NEEDLE BNS TUOHY OPEN SHLD
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7687151
• MDR Text Key: 114179269
• Report Number: 2618282-2018-00034
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 405482
• Device Lot Number: 7342831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other