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U.S. Department of Health and Human Services

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

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BECTON DICKINSON, S.A. BD¿ WHITACRE PENCIL POINT SPINAL NEEDLES; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
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.
 
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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 Key7313969
MDR Text Key101522955
Report Number3003152976-2018-00066
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
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
Date FDA Received03/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2022
Device Catalogue Number405076
Device Lot Number1709002
Date Manufacturer Received02/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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