MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 326638

Device Problem Volume Accuracy Problem (1675)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

It was reported that 588 bd ultra-fine¿ ii insulin syringes scale markings were defective.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, the scale marking was skewed.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 30-may-2022.D.4.Medical device lot #: 1214681 d.4.Medical device expiration date: 31-aug-2026 h.4.Device manufacture date: 02-aug-2021.D.4.Medical device lot #: 1088938 d.4.Medical device expiration date: 30-apr-2026 h.4.Device manufacture date: 29-mar-2021.H.6.Investigation: customer returned (91) 3/10cc, 8mm, 30g syringes in sealed poly bags from lot # 1088938.Customer states that the scale marking was skewed.Thirty out of 91 were tested using the plug gauge and all scale marking placements fell within specifications.Customer returned (389) 3/10cc, 8mm, 30g syringes in sealed poly bags with the shelf cartons from lot # 1214681.Customer states that the scale marking was skewed.Thirty out of 389 were tested using the plug gauge and all scale marking placements fell within specifications.A review of the device history record was completed for batch # 1088938 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.There was one (1) notification noted for missing print.A review of the device history record was completed for batch # 1214681 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that 588 bd ultra-fine¿ ii insulin syringes scale markings were defective.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, the scale marking was skewed.".

• Brand Name: BD ULTRA-FINE¿ II 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: 14465995
• MDR Text Key: 293635322
• Report Number: 1920898-2022-00356
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326638
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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