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

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.

• Brand Name: BD SYRINGE 0.3ML 31GA 6MM
• Type of Device: PISTON 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 Key: 12509419
• MDR Text Key: 272665765
• Report Number: 1920898-2021-01009
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324910
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• 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
• Patient Sequence Number: 1