MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ NEEDLES; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 400565

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ needles had a mix of product types in a pack and were out of specification.No serious injury or medical intervention was reported.

Manufacturer Narrative

The following fields have been updated with corrections: date of event: (b)(6) 2018.

Event Description

It was reported that bd needles had a mix of product types in a pack and were out of specification.No serious injury or medical intervention was reported.

Event Description

It was reported that bd¿ needles had a mix of product types in a pack and were out of specification.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: five epidural needles were received in juncos, pr on (b)(6) 2018.One of the needles was label as "good" and the other four needles were numerated from 1 to 4.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of needle length incorrect with lot #8137885 regarding item #400565.A review of the device history record was completed for lot #8137885.This lot was manufactured from 21 may 2018 to 24 may 2018 on arburg machine under order 105790645.The inspections related to length measurements were the effective length and visual 10x test.Test are performed during shift startup (16 units) and every 2 hours.Final inspection by quality was performed on (b)(6) 2018.According to the inspection record bdm1205 and ju-ifm-052, visual and functional characteristics were in compliance with the specification.Lot was released for packaging 29 may 2018 and packed as a bulk.The expiration date for this lot is 31 may 2023.A total of (b)(4) units were released on 30 may 2018.No machine intervention was reported for this lot.Preventive maintenance on the arburg machine was conducted as per schedule.Review of instrument calibrations included in the inspection records was conducted and they were calibrated within their calibration due dates.Juncos measured the finish point length as per sb1481 and drawing pd7567.All samples measure within drawing specification of 0.146 ± 0.008¿.Not confirmed: bd juncos could not confirmed customer indicated failure mode.Samples received as evidence were within specification.Not determined.Based on the investigation failure was not confirmed.Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not trigger a capa.

• Brand Name: BD¿ NEEDLES
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8150829
• MDR Text Key: 130060755
• Report Number: 2618282-2018-00075
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 400565
• Device Lot Number: 8137885
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other