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

Catalog Number 405075

Device Problems Dull, Blunt (2407); Defective Device (2588)

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

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1804004.Medical device expiration date: 2023-03-31.Device manufacture date: 2018-04-26.Medical device lot #: 1805013.Medical device expiration date: 2023-04-30.Device manufacture date: 2018-05-25.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 during use of the bd¿ whitacre pencil point spinal needle the needle hub has different color than the others.The following information was provided by the initial reporter: "i have a second question about the whitacre needle: ref.405075, same ref.But another needle.Now needle with white piece (hub) on end of the needle.Anesthesia says that it does not sting well.Lot number of the old needle is 1805013, production date: 2018-05.Lot number of the new needle is 1804004, production date: 2018-04¿.Pr#(b)(4) had been completed for the defect 'dull needle' however the manager informed (after complaint closure) that the defect was different color of the hub: "sorry to come back to this, but there was indeed no technical defect in these products.The issue was that the hub of one sample had a different color than other samples.This was the complaint that we originally raised".

Event Description

It was reported that during use of the bd¿ whitacre pencil point spinal needle the needle hub has different color than the others.The following information was provided by the initial reporter: "i have a second question about the whitacre needle: ref.405075, same ref.But another needle.Now needle with white piece (hub) on end of the needle.Anesthesia says that it does not sting well.Lot number of the old needle is 1805013, production date: 2018-05.Lot number of the new needle is 1804004, production date: 2018-04¿.(b)(4).Had been completed for the defect 'dull needle' however the manager informed (after complaint closure) that the defect was different color of the hub: "sorry to come back to this, but there was indeed no technical defect in these products.The issue was that the hub of one sample had a different color than other samples.This was the complaint that we originally raised".

Manufacturer Narrative

Investigation summary: needle hub color is incorrect.1 open sample was received from lot#1805013 (to avoid risk the sample was decontaminated.) 11 unopen samples were received from lot#1804004.The samples were inspected (magnifying glass and microscope used) and no defects were found.A device history review was performed for the reported lots, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Inspections and tests.There are two lots involved in this complaint: for lot 1804004: molding and assembly process are performed in bd puerto rico.Spinal needles arrived from puerto rico (cannula and stylet already assembled) and are manually assembled with the introductory hub in san agustín plant (according to ae-013 current version).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.For lot 1805013: molding and assembly process of spinal needles are performed in san agustín.After that, spinal needles are manually assembled with the introductory hub (according to ae-013 current version) to form the spinal needle set.Faulty spinal needles are discarded.For both lots: packaging process also takes place in san agustín plant.Spinal needled are manually placed in the packing machine.Once 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 aprox.) 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.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.Conclusion(s): the color assigned for reference (b)(4), according to sp1789 is smoked black.However, sample for lot 1805013 is manufactured at san agustín and the samples for lot 1804004 were manufactured in juncos.The technology used is not the same in both plants.Juncos uses epoxy resin, which is white.This changes the general perception of the color of the hub.Both lots have been manufactured according the product specification (grey color).Juncos has also reviewed the dhr finding no anomalies.The change in the shade of the color does not represent a defect itself.The manufactured process in san agustín has been properly documented and validated according to acr-r3-229.

• Brand Name: BD¿ WHITACRE PENCIL POINT SPINAL NEEDLE
• Type of Device: ANESTHESIA SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8466506
• MDR Text Key: 146921121
• Report Number: 3003152976-2019-00227
• Device Sequence Number: 1
• Product Code: BSP
• 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: 04/03/2019

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: Health Professional
• Device Catalogue Number: 405075
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other