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

Catalog Number 328468

Device Problems Failure to Deliver (2338); Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Skin Irritation (2076); Blood Loss (2597)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Review of the device history record was completed for batch# 8337681.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted that did not pertain to the complaint.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

Event Description

It was reported that foreign matter was found during use with a bd insulin syringe with the bd ultra-fine¿ needle.The following information was provided by the initial reporter, harm skin irritation, needle pain, needle blunt, bleeding, needle bending during use, fm-other on (b)(6) 2019.It was reported that the customer it was painful during injection, he hard time penetrating site, there was some bleeding and the needle bent during.Stated, saw some "white stuff" on his injection site.Verbatim: consumer stated: he has a hard time penetrating his injection site stated, needles are not sharp enough painful injections when he pushes really hard on syringe, he gets bruising and bleeding during injection, needle bends he does get his full dosage does not re-use stated, he pinches up and he does not hit his muscle during injection takes 1 shot per day; 20 units he's experienced above issues with most of his syringes because it happened multiple times, he cannot provide incident date.On (b)(6) 2019 same lot as above, same box stated, 30 minutes after his injection, he experienced swelling it was painful during injection, he hard time penetrating site, there was some bleeding and the needle bent during.Stated, saw some "white stuff" on his injection site stated, he iced the area that was swollen and the swelling went away did not see a doctor for any of the issues mentioned." 1 of 2 complaints, this complaint is for the event on (b)(6) 2019.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9245633
• MDR Text Key: 196271533
• Report Number: 1920898-2019-01201
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 328468
• Device Lot Number: 8337681
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• 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