MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1.0CC S/C 28G X 1/2" B-D ALLERGY SYRINGES; PISTON SYRINGE

Model Number	305500
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 1.0cc s/c 28g x 1/2" b-d allergy syringe experienced a breach in sterility, (product not sterile).The product defect was noted during use.The following information was provided by the initial reporter: material no: 305500, batch no: 8099970.Verbatim: issue(s): found 1 syringe needle poked thru shield - no injury to this consumer/user.Lot #: 8099970, catalog#: 305500, date of event: unknown.Samples available no discarded.
Event or Problem Description
It was reported that the 1.0cc s/c 28g x 1/2" b-d allergy syringe experienced a breach in sterility, (product not sterile).The product defect was noted during use.The following information was provided by the initial reporter: material no: 305500 batch no: 8099970.Verbatim: issue(s): found 1 syringe needle poked thru shield - no injury to this consumer/user lot #: 8099970 catalog#: 305500 date of event: unknown samples available no discarded.
Additional 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.A review of the device history record was completed for batch #8099970.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: 1.0CC S/C 28G X 1/2" B-D ALLERGY SYRINGES
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9775398
• Report Number: 1920898-2020-00195
• Device Sequence Number: 2951831
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• 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): 03/06/2020

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 Expiration Date: 04/30/2023
• Device Model Number: 305500
• Device Catalogue Number: 305500
• Device Lot Number: 8099970
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/06/2020
• 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