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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE Back to Search Results
Model Number 928856
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The customer's address is unknown:  (b)(6) usa has been used as a default.   there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 3287071. Medical device expiration date: na. Device manufacture date: 2013-11-27. Medical device lot #: 4027468. Medical device expiration date: na. Device manufacture date: 2013-11-27. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. This is the 1st complaint for the reported lot numbers. Due to these batches being made in 2013 and 2014, files are retained for 7 years, and no dhr review can be completed. 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. Investigation conclusion: a complaint lot history check was performed on lot # 3287071 for label information missing (expiration date). This is the 1st related complaint for label information missing (expiration date) on lot # 3287071. A complaint lot history check was performed on lot # 4027468 for label information missing (expiration date). This is the 1st related complaint for label information missing (expiration date) on lot # 4027468. 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 root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
Event Description
It was reported that 2 syringe 1. 0ml 31ga 8mm 10bag 500 pl/wg experienced missing label information. The following information was provided by the initial reporter: consumer called to inquire about expiration date on syringes. Consumer stated that the expiration date is not on the boxes.
 
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Brand NameSYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG
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 Key12471260
MDR Text Key271513376
Report Number1920898-2021-00989
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
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 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number928856
Device Catalogue Number928856
Device Lot NumberSEE H10
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 Received08/18/2021
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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