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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; SYRINGE WITH NEEDLE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 328440
Device Problems Defective Component (2292); Positioning Problem (3009)
Patient Problem Abscess (1690)
Event Date 08/08/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 that bd insulin syringe with the bd ultra-fine¿ needle had printing defects on the barrel scale and restricted plunger movement.It was also reported that ¿several patients were seen about two months ago for botox injections in the forehead they had patients develop red bumps and some puss from the bumps that lasted a few days and with one patient they had an abscess develop on their chin¿.These patients were treated with anti-biotics and/or steroid medications.
 
Manufacturer Narrative
Additional information: lot number has been provided.Medical device lot #: 8044941, medical device expiration date: n/a, device manufactured date: 03/13/2018.
 
Event Description
It was reported that bd insulin syringe with the bd ultra-fine¿ needle had printing defects on the barrel scale and restricted plunger movement.It was also reported that ¿several patients were seen about two months ago for botox injections in the forehead they had patients develop red bumps and some puss from the bumps that lasted a few days and with one patient they had an abscess develop on their chin¿.These patients were treated with anti-biotics and/or steroid medications.
 
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: event attributed to: required ingervention.Device single use?: no.Device returned to manufacture: no.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr due to unknown lot number.Severity: s_2__; unable to perform complaint lot history check for scale marking defective, plunger rod difficult to move and harm/skin irritation due to unknown lot number.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.
 
Event Description
It was reported that bd insulin syringe with the bd ultra-fine¿ needle had printing defects on the barrel scale and restricted plunger movement.It was also reported that ¿several patients were seen about two months ago for botox injections in the forehead they had patients develop red bumps and some puss from the bumps that lasted a few days and with one patient they had an abscess develop on their chin¿.These patients were treated with anti-biotics and/or steroid medications.
 
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Brand Name
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of Device
SYRINGE WITH NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7814567
MDR Text Key241264115
Report Number1920898-2018-00657
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908440035
UDI-Public00382908440035
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number328440
Device Lot Number8044941
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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