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

Catalog Number 405076

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/09/2018

Event Type  Injury  

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 during use of the bd¿ whitacre pencil point spinal needles the needle was used to perform spinal anesthesia on an orthopedic patient.The introducer needle was inserted by an experienced anesthesiologist.The spinal needle was then inserted but the patient jumped at some stage causing the needle to snap, possibly at the tip of the introducer needle.Needle had to be surgically removed under x-ray guided procedure.

Manufacturer Narrative

Medical device expiration date correction.The medical device expiration date field has been updated to reflect the corrected date of 08/31/2022.

Manufacturer Narrative

Investigation summary: lot number / product family history: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of needle broken with lot #1709002 regarding item #405076.Manufacturing records review: a review of the device history record was completed for the bd (b)(4) lots 6309783, 6341597 and 6347556 used on bd (b)(4) lot 1709002.The sub-assembly material number: 700006009, spinal needle 25 x 3 1/2in whitacre - bulk.Summary: the manufacturing records were reviewed for the incident lots 6309783, 6341597 and 6347556 and no discrepancy or related non-conformance were identified that could have contributed to the reported condition.Investigation at (b)(4) plant: upon investigation the claimed defect is confirmed: the needle is bent and broken.Eight unused samples were received: visual inspection shows no defects.Two retained samples were evaluated.Visual inspections shows no defect which may cause the breakage of the needle.Inspections and tests: molding and assembly process are performed in bd (b)(4).Spinal needles arrived from (b)(4) (cannula and stylet already assembled) and are manually assembled with the introductor in (b)(4) plant (according to ae-013 current version).This operation is performed with extremely care as the introductor hub is not attached to the cannula.During this process, the operator notices possible defects in the spinal needles.Faulty spinal needles are discarded.Packaging process also takes place in (b)(4) plant.Spinal needles are manually placed in the packing 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 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 advised.Conclusion: no root cause of the defect was found.The claimed defect is confirmed upon the evaluation of the sample received.However, no defects were found in unused samples and in retained samples.No non-conformances were found during dhr revision of final lot#1709002.No other issues which may cause its breakage at that point were found during manufacturing process.

• 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: 7313969
• MDR Text Key: 101522955
• Report Number: 3003152976-2018-00066
• 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,Followup
• Report Date: 03/27/2018

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: 08/31/2022
• Device Catalogue Number: 405076
• Device Lot Number: 1709002
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 02/14/2018; 02/14/2018
• Supplement Dates FDA Received: 03/20/2018; 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention