MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ WHITACRE PENCIL POINT SPINAL NEEDLES; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405076

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/18/2018

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 bd whitacre pencil point spinal needles are different from one another.Some have the introducer and some only have the needle.There was no report of exposure, serious injury, or medical intervention.

Event Description

It was reported that bd¿ whitacre pencil point spinal needles are different from one another.Some have the introducer and some only have the needle.There was no report of exposure, serious injury, or medical intervention.

Manufacturer Narrative

H.6.Investigation summary: 1 picture was received for investigation.8 unit cases were received as well: some spinal needles are without the introductory hub.One (1) picture was received for investigation.In the picture seemed that one component was missing.Eight (8) unit cases were received.The samples confirmed that in some spinal needles one of the components (introductory hub) was missing.Inspections and tests: 1.Molding and assembly process of spinal needles are performed in first place.2.After that, spinal needles are manually assembled with the introductory hub (according to ae-013 current version) to form the spinal needle set.This operation is performed with extremely care as the introductory hub is not attached to the cannula.During this process, the operator notices possible defects in the spinal needles.Faulty spinal needles are discarded.3.The spinal needles+ introducer hub are kept in small plastic bags (about 700 samples in each bag).During normal process, the set to be packed is handled by the shift leader.Operators don¿t take the set spinal needles on their own to star/continue with packed process.4.Packed machine and manual assembly post are separated in the area.Spinal needles are also manually placed in the packed machine.One packed in the blister, they are introduced in the unit case.Manufacturing inspections: in process inspection is performed according to ae-303/ae-012 (current version): packing: one strip of product per 4 bags (4,000 needles "approx".) is checked to verify: correct product packaging, product free of damages and dirt, etc.Packaging: during the packaging process of the product, 100% visual inspection of the product is performed by the operator.On the other hand, unit case inspection (25 spinal needles) is performed for each two rows and at the end of the pallet/lot according to ae-012.In case of faulty part, the operator: removes the defected product.In case of more than 2 defects/ 50 samples, the packing operator has to be informed.If the defect persists, the leader team or process inspector has to be aware.As the introductory hub assembly process is manual, it has been determined that the missing component most likely occurred due to human error.In response to this incident, assembly and packaging personnel have been retrained to avoid mistakes such as this in the future.

• Brand Name: BD¿ WHITACRE PENCIL POINT SPINAL NEEDLES
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8048669
• MDR Text Key: 128260905
• Report Number: 3003152976-2018-00477
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904050764
• UDI-Public: 382904050764
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 405076
• Device Lot Number: 1803004
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other