Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINE IV INSULIN SYRINGE; PISTON SYRINGE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD MEDICAL - DIABETES CARE BD MICRO-FINE IV INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Model Number 329424
Device Problem Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9119537.Medical device expiration date: 2024-07-31.Device manufacture date: 2019-04-29.Medical device lot #: 9140521.Medical device expiration date: 2024-08-31.Device manufacture date: 2019-05-20.Medical device lot #: 9168926.Medical device expiration date: 2024-09-30.Device manufacture date: 2019-06-17.Medical device lot #: 9189788.Medical device expiration date: 2024-09-30.Device manufacture date: 2019-07-08.Medical device lot #: 9196270.Medical device expiration date: 2024-10-31.Device manufacture date: 2019-07-15.Medical device lot #: 9231122.Medical device expiration date: 2024-11-30.Device manufacture date: 2019-08-19.Medical device lot #: 9287332.Medical device expiration date: 2024-12-31.Device manufacture date: 2019-10-14.Medical device lot #: 9294983.Medical device expiration date: 2024-12-31.Device manufacture date: 2019-10-21.Medical device lot #: 0099954.Medical device expiration date: 2025-06-30.Device manufacture date: 2020-04-08.Medical device lot #: 0160417.Medical device expiration date: 2025-08-31.Device manufacture date: 2020-06-08.Medical device lot #: 8302667.Medical device expiration date: 2024-01-31.Device manufacture date: 2018-10-29.Medical device lot #: 8351757.Medical device expiration date: 2024-03-31.Device manufacture date: 2018-12-17.Medical device lot #: 9322637.Medical device expiration date: 2025-02-28.Device manufacture date: 2019-11-18.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that several bd micro-fine¿ iv insulin syringes had issues with partial unsealed packaging units.There were 3 from lot 9119537, 14 from 9140521, 18 from 9168926, 30 from 9189788, 25 from 9196270, 5 from 9231122, 1 from 9287332, 38 from 9294983, 15 from 0099954, 256 from 0160417, 23 from 8302667, 36 from 8351757, and 3 from 9322637.The following information was provided by the initial reporter: "item 329424, a total of 467 units across 13 lot numbers were found to be partly unsealed".
 
Event Description
It was reported that several bd micro-fine¿ iv insulin syringes had issues with partial unsealed packaging units.There were 3 from lot 9119537, 14 from 9140521, 18 from 9168926, 30 from 9189788, 25 from 9196270, 5 from 9231122, 1 from 9287332, 38 from 9294983, 15 from 0099954, 256 from 0160417, 23 from 8302667, 36 from 8351757, and 3 from 9322637.The following information was provided by the initial reporter: "item 329424, a total of 467 units across 13 lot numbers were found to be partly unsealed".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-22.Investigation summary: customer returned (3) 1cc, 12.7mm, 28g syringes in blister packs from lot # 9119537, 9322637, 0160417, 0099954, 9294983, 9231122, 9196270, 9189788, 9168926, 9140521, 8351757, and 8302667.Customer states that the packaging was not sealed on one side.All returned syringes were examined and all blister packs were observed to be open.A review of the device history record was completed for batch# 9119537, 9322637, 0160417, 0099954, 9294983, 9287332, 9231122, 9196270, 9189788, 9168926, 9140521, 8351757, and 8302667.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD MICRO-FINE IV INSULIN SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key11121460
MDR Text Key247576208
Report Number1920898-2020-01798
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903294245
UDI-Public30382903294245
Combination Product (y/n)N
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number329424
Device Catalogue Number329424
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Date Manufacturer Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-