MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

Catalog Number	309703
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that the 1 syringe contained a foreign particulate.1 syringe had a large ink spot on the barrel.1 syringe had a crack on the base of the barrel.4 syringes had large pieces of plastic broken off of the plungers.Complaint via email.Email(s) attached on (b)(6) 2026 during compounding and on (b)(6) 2026 during visual inspection of lot 20260317 33fb47 rocuronium bromide 50mg/5ml (10mg/ml) several defects were discovered.1 syringe contained a foreign particulate.1 syringe had a large ink spot on the barrel.1 syringe had a crack on the base of the barrel.4 syringes had large pieces of plastic broken off of the plungers.The unit containing a foreign particulate is available for return.Details for your investigation: product: sterile syringe tray 5ml lot number: 5174810 part number: 309703 number of defective units: 7 defect type: foreign particulate.Ink sot on barrel.Crack on base of barrel.Large plastic pieces of plastic broken off plunger.Product complaint: (b)(4) quantity: (b)(4).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24781045
• Report Number: 9610847-2026-00151
• Device Sequence Number: 6134653
• Product Code: FMF
• UDI-Device Identifier: 30382903097037
• UDI-Public: (01)30382903097037(17)300430(10)5174810
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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: 309703
• Device Lot Number: 5174810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown