MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC SYRINGE 0.3ML 29GA 1/2IN BLS 400 SG; PISTON SYRINGE

Catalog Number	305935
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.4.The initial reporter also notified the fda.Medwatch report is (3600840000-2024-8040).H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material: 305935 batch#: 3216615 it was reported that the syringe 0.3ml 29ga 1/2in bls 400 sg stopper separated from the plunger.The following information was provided by the initial reporter: it was reported by the customer that when the insulin was drawn up, it was observed that the plunger was in 2 pieces, as evidenced by separation in the fluid.Not used on patient.Verbatim: rcc received a complaint via email.Email(s) attached.Procedure- administration of insulin.When the insulin was drawn up, it was observed that the plunger was in 2 pieces, as evidenced by separation in the fluid.Not used on patient.Product#: 305935 lot: 3216615r1 additional information provided on 05/01/2024: "plunger/rod intact and not damaged.Stopper was broken in 2 pieces.1 piece attached to plunger and the other was floating on the insulin that was in the syringe.".
Additional Manufacturer Narrative
Updated codes.
Event or Problem Description
Imdrf codes must be updated.

• Brand Name: SYRINGE 0.3ML 29GA 1/2IN BLS 400 SG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19249479
• Report Number: 3024508819-2024-01003
• Device Sequence Number: 7320977
• Product Code: FMF
• UDI-Device Identifier: 00382903059355
• UDI-Public: (01)00382903059355
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 305935
• Device Lot Number: 3216615
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown