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

Catalog Number 328438

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.Investigation results: summary: investigation summary: customer returned (1) 3/10 cc, 8 mm, 31 g syringe in an open poly bag from lot # 6179832.Customer states that the plunger rod was difficult to move.The returned syringe was tested and the plunger rod was able to be exercised in the barrel without any observed defects.A review of the device history record was completed for batch # 6179832 all inspections were performed per the applicable operations qc specifications.There were five (5) notifications (b)(4) noted that did not pertain to the complaint.Conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no capa is required at this time root cause: root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that the plunger rod on a bd insulin syringe with bd ultra-fine¿ needle was difficult to move.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• 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: 7519170
• MDR Text Key: 108895972
• Report Number: 1920898-2018-00314
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: 00382908438032
• 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: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328438
• Device Lot Number: 6179832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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