MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETY-LOK INSULIN SYRINGE; PISTON SYRINGE

Model Number	329461
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: unknown.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 the package information is not consistent with specifications registered in local license with a bd safety-lok¿ insulin syringe.The following information was provided by the initial reporter: the customer reported that the od information on shelf box and primary package shows 28g (0.35mm) and is not consistent with the specification registered in local license, which is 28g (0.36mm).The inconsistency is considered as non-compliance.
Additional Manufacturer Narrative
H.6.Investigation summary customer returned photos of photos of 1/2cc, 12.7mm, 28g syringes in blister packs from lot # 8085769 and a photo of the local license.Customer states that the od information on shelf box and primary package shows 28g (0.35mm) and is not consistent with the specification registered in local license, which is 28g (0.36mm).The photos were examined and exhibited a discrepancy in the gauge measurement, which is incorrect.A review of the device history record was completed for batch# 8085769.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion bd was 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.Root cause description bddc-20-2020-sa, has been initiated for insulin syringes: dimension typo in packaging graphics for 28g blister h3 other text : see h.10.
Event or Problem Description
It was reported that the package information is not consistent with specifications registered in local license with a bd safety-lok¿ insulin syringe.The following information was provided by the initial reporter: the customer reported that the od information on shelf box and primary package shows 28g (0.35mm) and is not consistent with the specification registered in local license, which is 28g (0.36mm).The inconsistency is considered as non-compliance.

• Brand Name: BD SAFETY-LOK INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10016408
• Report Number: 1920898-2020-00448
• Device Sequence Number: 2553693
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 329461
• Device Catalogue Number: 329461
• Device Lot Number: 8085769
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/01/2020
• 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