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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 6MM PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 6MM PISTON SYRINGE Back to Search Results
Catalog Number 324910
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. 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: lot # : 8134942 ¿ device expiration date : 06/30/2023 ¿ device manufacture date : 05/14/2018. Lot # : 7254984 ¿ device expiration date : unknown ¿ device manufacture date : 11/09/2017. Lot # : 7317955 ¿ device expiration date : 10/31/2022 ¿ device manufacture date : 11/13/2017. Lot # : 7317969 ¿ device expiration date : 11/30/2022 ¿ device manufacture date : 11/13/2017. The customer's address is unknown. (b)(6), usa has been used as a default. Investigation summary : exec summary - no samples (including photos) were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined. A review of the complaint lot history check was performed for each of the multiple batches as listed above and this is the 1st related complaint for incorrect/missing label information (expiration date) on each of these lot #s. No non-conformances were raised in association with this type of event for these lots concluding all inspections were performed as per the applicable operations and met qc specifications. Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time. Dhr review - a lot history review for each of the multiple batches as listed above were carried out and no related non conformances were raised in association with these packaged lots concluding all inspections were performed as per the applicable operations and met qc specifications.
 
Event Description
It was reported that 4 bd syringe 0. 3ml 31ga 6mm had label information issues. The following information was provided by the initial reporter: the customer enquired regarding the expiry date for certain bd items.
 
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Brand NameBD SYRINGE 0.3ML 31GA 6MM
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12509419
MDR Text Key272665765
Report Number1920898-2021-01009
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 company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number324910
Device Lot NumberSEE H.10
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 Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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