MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 1ML ST BULK CONVENIENCE PAK; PISTON SYRINGE

Catalog Number	309701
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.Other lot number includes 3212533 and other expiration date includes 2027-10-31.If a device evaluation and/or device history review is completed, a supplemental report will be filed.Other lot number device manufacture date is 2023-08-21.
Event or Problem Description
It was reported that the bd syringe 1ml st bulk convenience pak leaked.The following information was provided by the initial reporter: "we are currently experiencing multiple leaking syringes with two lot numbers." we have received the below product problem report.Stevens ref # pc (b)(4) has been assigned to this issue.Upon completion, please provide a quality investigation letter detailing your findings.Please advise on next steps for quality investigation and customer resolution: ________________________________________ product problem report product information product code: 309701 product description: syringe hypo 1cc l/s conv pack && bulk ster bx/25 lot/serial #: (b)(6) expiry date: 2027-10-31 problem information we are currently experiencing multiple leaking syringes with two lot numbers.Occurrences: recurring reporter information reporter name: xxxxxx reporter position/department: material mgmt reporter phone: xxxxx reporter email: xxxxx@wrha.Mb.Ca site information xxxxxx sample information incident samples: yes -pending qty representative samples: yes- pending qty no adverse event reported ------------------------------------------- please find attached product complaint(s) for your investigational action for resolution, awareness and or replacement: scmss (internal) complaint #: (b)(4).Product name: syringe, iv sterile 1 ml product code & lot # (if available): 309701 lots #(s): 3212533/2321369 site: concordia hospital/pharmacy materials management contact at the site: xxxxx vendor/industry partner: 1.Respond to everyone included in this email-all communication until resolution of investigation.2.Include scmss (internal) complaint number for reference in all communication 3.Contact site mat man (cc¿d here) directly for any questions concerning complaint details and/or returning of samples for investigation.If questions are clinical in nature- mat man to contact confidential-identified plaintiff for requested answers and forward to vendor.Materiel management: please keep all defective product(s).Please consult with vendor to validate if they accept contaminated products and/or if they require the return in a hazardous bag.If the contaminate is available only [e.G.Item discarded], please send a photo of the contaminate.Please follow site policy related to safe handling of contaminated products/goods.If product was involved in a critical incident, please have manager contact legal for assistance with any inquiries from vendors/industry partners concerning either the patient and or defective product in question.

• Brand Name: BD SYRINGE 1ML ST BULK CONVENIENCE PAK
• 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: 18996867
• Report Number: 1920898-2024-00098
• Device Sequence Number: 15506242
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: (01)30382903097013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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: 309701
• Device Lot Number: 2321369
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown