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

Catalog Number 326631

Device Problem Failure to Align (2522)

Patient Problem No Information (3190)

Event Date 11/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: customer returned (1) 3/10cc, 12.7mm, 29g syringe in an open poly bag from lot # 7205905.Customer states that the scale was misaligned.The returned syringe was testes using the plug gauge and the placement of the scale markings fell within specifications.A review of the device history record was completed for batch # 7205905 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd ultra-fine¿ insulin syringe scale was "misaligned".

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: INSULIN 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8096264
• MDR Text Key: 128277715
• Report Number: 1920898-2018-00877
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 326631
• Device Lot Number: 7205905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• 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
• Patient Outcome(s): Other