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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET; ANESTHESIA CONDUCTION KIT
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BD (SUZHOU) BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 401622
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2022
Event Type  malfunction  
Event Description
It was reported while using bd anesthesia 17gax8cm durasafe foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: found that the anesthesia puncture package had a foreign matter similar to hair.The anesthesia puncture package was replaced immediately and the anesthesia was successful.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd anesthesia 17gax8cm durasafe foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: found that the anesthesia puncture package had a foreign matter similar to hair.The anesthesia puncture package was replaced immediately and the anesthesia was successful.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 04-nov-2022.H6: investigation summary: a device history review was conducted for lot number 2048492.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally the sample submitted by the facility was reviewed by our quality engineers, who determined that the identity of the foreign matter was hair from the clothing of one of our operators.To prevent a reoccurrence of this event our facility has issued awareness training to the packaging personnel.H3 other text : see h10.
 
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Brand Name
BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15715934
MDR Text Key306803063
Report Number3014704491-2022-00536
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number401622
Device Lot Number2048492
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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