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

Catalog Number	928855
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 had fluid in the syringes and the syringes leaked.No serious injury or medical intervention was reported.Verbatim: "material no.: 928855, batch no.: 8121963.It was reported by the consumer that there was fluid in the syringes and the syringes leaked.Verbatim: consumer reported fluid in syringes, stated that the syringes leaked.Consumer provided lot # 8121963, 30g, 3/10ml, 8mm (product # 928855).She would not provide any additional information, stated that her attorney advised her not to give any information.She called for mailing address to send syringes for testing.I advised her to have her attorney contact us".
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 # 8121963 all inspections were performed per the applicable operations qc specifications.There was one (1) notification (b)(4) noted that did not pertain 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.
Event or Problem Description
It was reported that bd¿ insulin syringe had fluid in the syringes and the syringes leaked.No serious injury or medical intervention was reported.Verbatim: "material no.: 928855, batch no.: 8121963.It was reported by the consumer that there was fluid in the syringes and the syringes leaked.Verbatim: consumer reported fluid in syringes, stated that the syringes leaked.Consumer provided lot # 8121963, 30g, 3/10ml, 8mm (product # 928855).She would not provide any additional information, stated that her attorney advised her not to give any information.She called for mailing address to send syringes for testing.I advised her to have her attorney contact us.".

• Brand Name: BD¿ INSULIN SYRINGE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8387972
• Report Number: 1920898-2019-00222
• Device Sequence Number: 11507579
• Product Code: FMI
• UDI-Device Identifier: 00311917025278
• UDI-Public: 00311917025278
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/13/2019

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 Catalogue Number: 928855
• Device Lot Number: 8121963
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/13/2019
• 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