MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 8MM 90; PISTON SYRINGE

Model Number 328290

Device Problem Material Separation (1562)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.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 and this is the 1st related complaint for hub separates on this lot #.No non-conformances 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.Capa/sa - based on the above no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - a lot history review was carried out and no related non conformances 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 0.5ml 8mm 90 hub separated.The following information was provided by the initial reporter : the consumer reported that the needle assembly detached from the syringe inside the orange needle cover and could not be removed.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/4/2021.H.6.Investigation: customer returned a single 0.5ml syringe with no other forms of identification.The syringe had its needle shield and hub separate from the barrel.The hub has become lodged inside the shield.There is no damage to either the connector at the distal tip of the barrel or its respective needle hub.No signs of use and no other defects found.A review of the device history record was completed for batch# 0174623.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted for high shield pulls.Based on the sample received, bd was able to confirm the customer¿s indicated failure of needle hub separation.Capa#1630423 was initiated.H3 other text : see h.10.

Event Description

It was reported that 1 bd syringe 0.5ml 8mm 90 hub separated.The following information was provided by the initial reporter : the consumer reported that the needle assembly detached from the syringe inside the orange needle cover and could not be removed.

• Brand Name: BD SYRINGE 0.5ML 8MM 90
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12475554
• MDR Text Key: 271512304
• Report Number: 1920898-2021-00991
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282906
• UDI-Public: 00382903282906
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328290
• Device Catalogue Number: 328290
• Device Lot Number: 0174623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1