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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. WHITACRE SET 25GA 3.50 IN FOR INDIA ANESTHESIA CONDUCTION KIT

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BECTON DICKINSON, S.A. WHITACRE SET 25GA 3.50 IN FOR INDIA ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405129
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 01/11/2021
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 #: 1901013, medical device expiration date: 2023-12-31, device manufacture date: 2019-01-29. Medical device lot #: 1808018, medical device expiration date: 2023-07-31, device manufacture date: 2018-08-31. A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that 23g were found in the box of 50 whitacre set 25ga 3. 50 in for india needles, both in lots 1901013 and 1808018. The following information was provided by the initial reporter: "wrong product (spinal needle 23g-405120) inside the box of whitacre 25g-405129 during supply of 4 box i. E. 100 units of bd whitacare 25g of ref no-405129 to a customer, distributor had found bd spinal 23g of ref no-405120 inside all the boxes instead of whitacare 25g. Outer part of the box were of bd whitacare 25g with batch no-1901013 & 1808018 each containing 50 units. But inside each box they had found bd spinal 23g, lot no-1906017. ".
 
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Brand NameWHITACRE SET 25GA 3.50 IN FOR INDIA
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key11276487
MDR Text Key230756739
Report Number3003152976-2021-00062
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405129
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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