MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ INSULIN SYRINGE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	928855
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: n/a.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ insulin syringe came with a mix of product types.This was discovered during use.The following information was provided by the initial reporter: material no.928855, batch no.7261532.It was reported that a shelf carton contained mixed product.Out of 10 bags in the shelf carton, 9 were 0.3ml and one was 0.5ml.Verbatim: issue: consumer reported out of 10 bags in the box of 3/10 ml, 30g, 8mm syringes she found 1 bag was a bag of.5ml.30g, 8mm syringes.She did not use these.
Additional Manufacturer Narrative
H.6.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.A review of the device history record was completed for batch #7261532.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.As no samples and/or photo(s) were received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.H3 other text : see section h.10.
Event or Problem Description
It was reported that bd¿ insulin syringe came with a mix of product types.This was discovered during use.The following information was provided by the initial reporter: material no.928855 batch no.7261532 it was reported that a shelf carton contained mixed product.Out of 10 bags in the shelf carton, 9 were 0.3ml and one was 0.5ml.Verbatim: issue: consumer reported out of 10 bags in the box of of 3/10 ml, 30g, 8mm syringes she found 1 bag was a bag of of.5ml.30g, 8mm syringes.She did not use these.

• Brand Name: BD¿ INSULIN SYRINGE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9534211
• Report Number: 1920898-2019-01487
• Device Sequence Number: 2371608
• Product Code: FMI
• UDI-Device Identifier: 00311917025278
• UDI-Public: 00311917025278
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K955235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: Lay User/Patient
• Device Model Number: 928855
• Device Catalogue Number: 928855
• Device Lot Number: 7261532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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