MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 326631

Device Problem Volume Accuracy Problem (1675)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd ultra-fine¿ 3/10ml insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: the scale marking was crooked.

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd ultra-fine¿ 3/10ml insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: the scale marking was crooked.

Event Description

It was reported that the bd ultra-fine¿ 3/10ml insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: the scale marking was crooked.

Manufacturer Narrative

The following fields were updated due to additional information: medical device lot #: 1144020 medical device expiration date: 30jun2026 device manufacture date: 24may2024 device available for eval yes returned to manufacturer on: 08mar2022 investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13593434
• MDR Text Key: 286255173
• Report Number: 1920898-2022-00124
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326631
• Device Lot Number: 1144020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 07/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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