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

Model Number 928856

Device Problem Leak/Splash (1354)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.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.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 syringe 1.0ml 31ga 8mm 10bag 500 pl/wg had a plunger rod that was difficult to move.The following information was provided by the initial reporter: "family member of consumer reported plunger rod difficult to move.".

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 1144711, d4: medical device expiration date: 2026-06-30, h4: device manufacture date: 2021-05-24.D4: medical device lot #: 0125633, d4: medical device expiration date: 2025-05-31,.H4: device manufacture date: 2021-05-04 d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-13.H6: investigation summary: customer returned a single syringe in a polybag labeled for 1ml, 31 gauge, 8mm syringes from lot 1144711.The plunger rod can be moved through the barrel of the syringe without issue.Uniform movement and resistance throughout the length of the syringe.No damage to the stopper.No defects found and syringe functions as intended.No samples (including photos) were returned from lot 0125633.Therefore, the complaint could not be confirmed for this lot and the root cause could not be determined.A review of the device history record was completed for batch # 1144711.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.A review of the device history record was completed for batch # 0125633.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of difficulty moving the plunger rod.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported syringe 1.0ml 31ga 8mm 10bag 500 pl/wg had a plunger rod that was difficult to move.The following information was provided by the initial reporter: "family member of consumer reported plunger rod difficult to move.".

• Brand Name: SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG
• 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: 12550675
• MDR Text Key: 274488979
• Report Number: 1920898-2021-01029
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• 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: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2020
• 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