MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE 30ML LL TIP CONV PAK

Catalog Number	305618
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe 30ml ll tip conv pak had scale marking issue.It was reported by customer that no markings on affected syringes in pack.Verbatim: rcc received a complaint via phone.Pir attached.No markings on affected syringes in pack.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of scale marking issue was confirmed upon inspection of the sample.Analysis of the sample showed that the syringe barrel had no scale markings.Bd determined that the cause of the failure was likely a result of a jam occurring at our scale marking printing machine.Manufacturing associates will be shown the defective sample to increase their awareness to prevent the recurrence of the failure observed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

• Brand Name: BD SYRINGE 30ML LL TIP CONV 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: 19577207
• Report Number: 9610847-2024-00174
• Device Sequence Number: 8470575
• Product Code: FMF
• UDI-Device Identifier: 00382903056187
• UDI-Public: (01)00382903056187
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/16/2024

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: 305618
• Device Lot Number: 4037253
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown