MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 305934

Device Problem Volume Accuracy Problem (1675)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 safetyglide¿ insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: no scale.

Manufacturer Narrative

The following updated information has been received: d.4.Medical device lot: 1139882.D.4 medical device expiration date: 31-may-2026.D.10 device returned to manufacturer? d.10 date received?: 05-apr-2022.H.4 device manufacture date?: 19-may-2021 h3 other text : see h10.

Event Description

It was reported that the bd safetyglide¿ insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: no scale.

• Brand Name: BD SAFETYGLIDE¿ 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: 14000243
• MDR Text Key: 288798533
• Report Number: 1920898-2022-00219
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 305934
• Device Lot Number: 1139882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2021
• 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