MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 30GA 8MM; PISTON SYRINGE

Catalog Number 326638

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: exec summary: samples were received and an investigation was performed.A review of the complaint lot history check was performed and this is the 7th related complaint for needle hub separates on this lot #.No non-conformance's were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Samples returned: customer returned (1) 3/10cc, 8mm, 30g syringe in an open poly bag from lot # 0286309.Customer states that the hub separation is occurring before use.The returned syringe was examined and exhibited the hub-needle/shield assembly separated from the barrel.Manufacturing ((b)(4)) will be notified of this issue.Capa/sa: capa (b)(4) has been opened to address this issue.Dhr review: a lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.

Event Description

It was reported that 1 bd syringe 0.3ml 30ga 8mm hub separated from the device.The following information was provided by the initial reporter: the user reported that the hub separation occurred before use.

• Brand Name: BD SYRINGE 0.3ML 30GA 8MM
• 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: 12520103
• MDR Text Key: 272941228
• Report Number: 1920898-2021-01013
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326638
• Device Lot Number: 0286309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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