MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB; PISTON SYRINGE

Catalog Number	305540
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material #: 305540; batch#: 4107109.It was reported that the bd syringe allergy 1ml w/ndl 27x1/2 rb package seal integrity was poor / questionable.The following information was provided by the initial reporter: verbatim: rcc received a complaint via community.Pir attached.One of the syringes in the pack was melted to the seal of the package.It appears the packet was never sealed properly.No patients were affected.Additional information provided: 1.Sample available is mentioned as yes, are you able to provide the address of the facility for us to ship the return label? a.Yes, i can mail the sample back.The address of our office is (b)(6).2.Are you able to provide photos of the damaged items? a.Yes, would you like them via email? 3.Can you describe the external condition of the box upon receipt, any signs of mishandling? a.I cannot ¿ these were shipped x1 month ago.4.Did you notice any unusual sounds or shifting inside the box when handling it? a.No, we noticed that the package was not sealed properly.
Additional Manufacturer Narrative
Investigation summary: 1 sample was received and tested by our quality team with the customer's complaint of packaging damaged.The complaint was immediately verified upon initial visual analyses due to the seal having pressed and melted a syringe into the edge of tray.The manufacturer has been notified of this failure and the root cause has been traced to an operator error and quality control deficiency when loading trays before being sealed and subsequent failure to realize a defective product.Corrective action is not necessary due to the plant's closure since this device was produced.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Sample received.

• Brand Name: BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20717739
• Report Number: 1920898-2024-00151
• Device Sequence Number: 8334455
• Product Code: FMF
• UDI-Device Identifier: 00382903055401
• UDI-Public: (01)00382903055401(11)240623(17)290430(10)4107109
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: Health Professional
• Device Catalogue Number: 305540
• Device Lot Number: 4107109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown