MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE ALLERGY 1ML W/NDL 26X3/8 IB; PISTON SYRINGE

Model Number	305539
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8015599.Medical device expiration date: 2023-02-28.Device manufacture date: 2018-01-15.Medical device lot #: 8059822.Medical device expiration date: 2023-03-31.Device manufacture date: 2018-02-28." 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 prior to use it was discovered that the scale marking were missing with a bd syringe allergy 1ml w/ndl 26x3/8 ib.The following information was provided by the initial reporter: it was reported that numerous syringes were found to have no graduation markings and bent needles.
Event or Problem Description
It was reported that prior to use it was discovered that the scale marking were missing with a bd syringe allergy 1ml w/ndl 26x3/8 ib.The following information was provided by the initial reporter: it was reported that numerous syringes were found to have no graduation markings and bent needles.
Additional Manufacturer Narrative
H.6 investigation summary: customer returned photos of 1ml syringes in an open tray.Customer states that numerous syringes were found to have no graduation markings and bent needles.The attached photos were examined, and no defects were observed on any of the syringes shown.A review of the device history record was completed for batch # 8015599.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.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.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: BD SYRINGE ALLERGY 1ML W/NDL 26X3/8 IB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9751127
• Report Number: 1920898-2020-00172
• Device Sequence Number: 2921305
• Product Code: FMF
• UDI-Device Identifier: 30382903055396
• UDI-Public: 30382903055396
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,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: Other
• Device Model Number: 305539
• Device Catalogue Number: 305539
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/25/2020
• 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