MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	305540
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd allergy syringe tray with bd precisionglide¿ permanently attached needle there were scale marking issues.There was no report of patient impact.The following information was provided by the initial reporter: we have received a quality complaint on product sold to our customer.Item: 305540.Quantity affected: 2 cs.Serial/lot number: (b)(6).Po : 4516148201.Reported issue: these are 1 ml syringes.A lot of the syringes only go up to 0.9 volume.The last.10 of volume is missing.I have opened multiple packages, and in each box of 25, at least 6-7 are not labeled correctly.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with additional information: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2321612 d.4.Medical device expiration date: 31-dec-2027 h.4.Device manufacture date: 17-nov-2022 d.4.Medical device lot #: 2321604 d.4.Medical device expiration date: 31-dec-2027 h.4.Device manufacture date: 17-nov-2022.
Event or Problem Description
It was reported while using bd allergy syringe tray with bd precisionglide¿ permanently attached needle there were scale marking issues.There was no report of patient impact.The following information was provided by the initial reporter: we have received a quality complaint on product sold to our customer.Item: 305540 quantity affected: 2 cs serial/lot number: (b)(6) po : 4516148201 reported issue: these are 1 ml syringes.A lot of the syringes only go up to 0.9 volume.The last.10 of volume is missing.I have opened multiple packages, and in each box of 25, at least 6-7 are not labeled correctly.
Additional Manufacturer Narrative
Investigation summary: customer returned total of (b)(4) 1ml 27g allergy syringes, (b)(4) were in unopened trays, 33 were out of the trays.It was reported by customer that "these are 1 ml syringes.A lot of the syringes only go up to 0.9 volume.The last.10 of volume is missing.All the syringes visually examined and observed 33 syringes with missing 1ml unit marking.The print on syringes was not properly applied and the complaint has been verified.The root cause is due to improper application of ink during production and the manufacturing facility has been made aware of the issue.A review of the device history record was completed for batch# 2321612.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification (b)(4) noted that did not pertain to this complaint.There were two (2) notifications (b)(4) noted for print issues.
Event or Problem Description
Samples received.

• Brand Name: BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17159563
• Report Number: 1920898-2023-00370
• Device Sequence Number: 17908811
• Product Code: FMF
• UDI-Device Identifier: 00382903055401
• UDI-Public: (01)00382903055401
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2024

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 Catalogue Number: 305540
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 08/10/2023; 04/24/2024
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 09/11/2023; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown