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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SAFE-CLIP¿; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON BD SAFE-CLIP¿; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 328235
Device Problem Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2022
Event Type  malfunction  
Event Description
It was reported that the bd safe-clip¿ was not cutting through the needles.The following information was provided by the initial reporter, translated from spanish: "a call is received from the patient's caregiver."i think the needle cutter is full" he is told that the device has a capacity for 1500 units and that its useful life is 3 years.Likewise, re-training is scheduled for (b)(6) 2022 15+30 to validate the operation of the device.Therefore, we proceed to report an adverse event.A needle cutting exercise is carried out and it is evident that the needle cutter does not cut.Recommendations are given on the correct use and storage of the device.".
 
Manufacturer Narrative
(b)(4).Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: customer returned a video of a safeclip pen needle cutter.The user is able to insert the pen needle into the safeclip, but it cannot trim the pen needle cannula properly.Wear and tear over many uses may have dulled the safeclip to this extent.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Based on the sample received, embecta was able to confirm the customer¿s indicated failure of the safeclip being unable to cut pen needles.The root cause of the safeclip not being able to cut needles is most likely a significant number of uses over an extended period of time, resulting in wear.
 
Event Description
It was reported that the bd safe-clip¿ was not cutting through the needles.The following information was provided by the initial reporter, translated from spanish: "a call is received from the patient's caregiver."i think the needle cutter is full" he is told that the device has a capacity for 1500 units and that its useful life is 3 years.Likewise, re-training is scheduled for (b)(6) 2022 15+30 to validate the operation of the device.Therefore, we proceed to report an adverse event.A needle cutting exercise is carried out and it is evident that the needle cutter does not cut.Recommendations are given on the correct use and storage of the device.".
 
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Brand Name
BD SAFE-CLIP¿
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16065649
MDR Text Key306793637
Report Number2243072-2022-02243
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K943683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number328235
Device Catalogue Number328235
Device Lot Number2047001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2022
Initial Date FDA Received12/28/2022
Supplement Dates Manufacturer Received01/17/2023
Supplement Dates FDA Received01/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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