MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD LO-DOSE¿ U-100 INSULIN SYRINGE WITH NEEDLE; INSULIN SYRINGE AND NEEDLE

Catalog Number	329461
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using a bd lo-dose u-100 insulin syringe with needle, too much resistance was encountered when pressing the plunger.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: on 24jan2018, holdrege received thirty-seven (37) 0.5ml, 12.7mm, 28g syringes sealed in blisterpaks with shelf carton from batch# 7024847.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah on 06 feb 2018, all returned samples were cycle tested and there were no indications or notations of increased force required to complete the test.All samples were additionally visualized in their assembled configuration and all stoppers and plunger rods were found to be unremarkable.As there were no samples exhibiting the customer's described defect, bd is unable to confirm the reported defect condition at this time.Root cause cannot be determined at this time as the issue is unconfirmed.A review of the device history record was completed for batch# 7024847.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200690135] noted that did not pertain to the complaint.Based on the investigation, no additional investigation and no capa is required at this time.

• Brand Name: BD LO-DOSE¿ U-100 INSULIN SYRINGE WITH NEEDLE
• Common Device Name: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7238196
• Report Number: 1920898-2018-00014
• Device Sequence Number: 16399691
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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
• Operator of Device: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 329461
• Device Lot Number: 7024847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other