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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE II¿ NEEDLE PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE II¿ NEEDLE PISTON SYRINGE Back to Search Results
Catalog Number 328279
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Swelling (2091)
Event Date 04/19/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: n/a investigation summary: level b investigation: complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_3__; occurrence: a complaint history check was performed and this is the 1st related complaint for harm/skin irritation on lot # 8008790. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. If samples are received in the future the complaint will be reopened for further investigation. A review of the device history record was completed for batch# 8008790. All inspections and challenges were performed per the applicable operations qc specifications. There was one (1) notification [(b)(4)] noted for adhesive on cannula. Investigation conclusion: as no samples and/or photo(s) were 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 complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that bd insulin syringe with bd ultra-fine ii¿ needle was used and caused the patient to swell all over. The following information was provided by the initial reporter: material no: 328279, batch no: 8008790, it was reported that the consumer experienced swelling all over when she uses bd syringes verbatim: consumer stated when she uses bd syringes, she's experiencing "swelling" all over. Stated she has not been to a doctor but intends to go. Stated she is a "drug user". Stated she has to elevate her legs because they really swell up. Wanted to know if bd sold syringes that have already been used. Stated she found something online pertaining to bd selling syringes that have been used. Stated she will make doctors appointment today after speaking with me. Stated issue with swelling has been happening for two weeks. Lot: 8008790, item: 328279, exact occurrence date, unknown. Consumer mentioned (b)(6), was not clear on why it was mentioned. Samples coming in compromised. Syringes not being used for insulin (when i asked, she said for "drugs"). Will not be sending mail kit because consumer mentioned (b)(6) and stated she is a user.
 
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Brand NameBD INSULIN SYRINGE WITH BD ULTRA-FINE II¿ NEEDLE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8582415
MDR Text Key144143527
Report Number1920898-2019-00425
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328279
Device Lot Number8008790
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/06/2019 Patient Sequence Number: 1
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