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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETY-LOK¿ INSULIN SYRINGE
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BD MEDICAL - DIABETES CARE BD SAFETY-LOK¿ INSULIN SYRINGE Back to Search Results
Catalog Number 329460
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem Needle Stick/Puncture (2462)
Event Date 06/07/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.(b)(6).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 the bd safety-lok" insulin syringe was difficult to operate and the safety mechanism is not being activated.Nurse technician had a needle stick injury.Due the needle stick there was contact with the patient blood and the professional.Rapid test performed in the patient and the professional.Found during use.
 
Manufacturer Narrative
Correction from expiration date 09/30/2018 to expiration date: 09/30/2019.
 
Event Description
It was reported that the bd safety-lok¿ insulin syringe was difficult to operate and the safety mechanism is not being activated.Nurse technician had a needle stick injury.Due the needle stick there was contact with the patient blood and the professional.Rapid test performed in the patient and the professional.Found during use.
 
Manufacturer Narrative
Investigation summary: customer returned 1cc 13mm 29g syringes and two open blister packs with lot #4176651.Customer states safety mechanism is not being activated.The returned syringes were examined and both exhibited the hub-needle/shield assembly separated from the barrel.Capa # (b)(4) has been opened to address this issue.A review of the device history record was completed for batch #4176651.All inspections were performed per the applicable operations qc specifications.There were two notifications [200570419, 200561806] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure ¿ hub separation.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure - needle stick.Investigation conclusion: possible root causes for hub separates: increase jams from the worn or incorrect swing fingers causing double load on the hub loader putting extra stress on the hubs causing cracking.Raised hub detection is only challenged once a week which limits the ability to detect this defect in a timely manner.Capa # (b)(4) has been opened to address this issue.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
 
Event Description
It was reported that the bd safety-lok¿ insulin syringe was difficult to operate and the safety mechanism is not being activated.Nurse technician had a needle stick injury.Due the needle stick there was contact with the patient blood and the professional.Rapid test performed in the patient and the professional.Found during use.
 
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Brand Name
BD SAFETY-LOK¿ INSULIN SYRINGE
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7650450
MDR Text Key112733774
Report Number1920898-2018-00446
Device Sequence Number1
Product Code FMF
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,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Expiration Date09/30/2019
Device Catalogue Number329460
Device Lot Number4176651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Date Manufacturer Received06/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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