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

Catalog Number 405482

Device Problem Incorrect Measurement (1383)

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

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that there are bd¿ needle bns tuohy open should that have needles that are longer than they should be.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: photos were provided in support of this complaint.No samples were returned.A photo from catalog 405482 lot 7334506 was attached to parent record of complaint (b)(4) for evaluation.Per photo, sample was measured and value on photos was 0.1561¿.Second picture shows two needles with visually difference at finish point length.The manufacturing records were reviewed for the incident lot and no discrepancies or non-conformances were reported.As per procedure, cannula ¿finish point length¿ value is not a release criteria requirement.Reference specification at part drawing is 0.146 in +- 0.005 in.(0.141¿ to 0.151¿).The picture provided shows the finish point length is out of reference specification (0.156').As a result, bd was able to verify the reported issue.Bd juncos finish point length measurement is a reference length which means that finish point length is not a critical specification and do not impact the quality or function of the product if the required dimensions are within spec.Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not trigger a capa.A supplier quality alert request has been sent to the (b)(4) supplier for further analysis.Investigation conclusion: possible root cause may be related to the manufacturing process at supplier site.Correction: due to an it issue beginning on 7/3/2018, 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 manufacturer: no.

Event Description

It was reported that there are bd¿ needle bns tuohy open shld that have needles that are longer than they should be.There was no report of exposure, serious injury or medical intervention.

• 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: 7805775
• MDR Text Key: 118001217
• Report Number: 2618282-2018-00043
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904054823
• UDI-Public: 382904054823
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 7334506
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 08/01/2018
• Supplement Dates FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other