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	03/31/2026
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
It was reported by a customer that one syringe was found to contain a foreign particulate, and one syringe had excessively slanted syringe markings.Complaint via email.On 03/31/2026, during visual inspection of lot: 20260325-2668c6, rocuronium bromide 50mg/5ml (10mg/ml) -1, one syringe was found to contain a foreign particulate and one syringe had excessively slanted syringe markings.These units are available for return.Details for your investigation: product: sterile syringe tray 5ml lot number: 5174808/5212183/5218656 part number: 309703 number of defective units: 2 defect type: foreign particulate and defective syringe markings product complaint: (b)(4) please let me know the results of the investigation additional information received on 08apr2026: as two issues have been reported¿foreign matter and a scale marking issue¿please clarify which specific lot is associated with each issue.The batch/lot numbers provided are 5174808, 5212183, and 5218656.With three different lots being used for this batch, we do not know which lots are the one with defects.There are only 2 units with defects.The numbers i had listed were the total amount we had received.As the affected quantities seem to be high, would you like to receive a credit? we do not need a credit, as the amount of units is only 2.

• 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: 24897103
• Report Number: 9610847-2026-00167
• Device Sequence Number: 15614893
• Product Code: FMF
• UDI-Device Identifier: 30382903097037
• UDI-Public: (01)30382903097037(17)300430(10)5174808
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown