MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE 20ML LL TIP CONV PAK

Catalog Number	305617
Medical Device Problem Codes	Break (1069); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
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 that bd syringe 20ml ll tip conv pak tip breakage and scale marking issue.It was reported by the customer that syringe tip broken, or the graduation on the syringe is wrong, or the graduation is missing.We also found a hair in a sterile syringe tray.Verbatim: rcc received a complaint via email.Chc complaint reference #: (b)(4).Hospital complaint reference #: (b)(4).Correspondence language: french.Cat# of product being complained: bd305617.Description of product: syringe luer-lok st 20cc 10ea/tray 12trays/ca.Lot or s/n: (b)(6).Complaint category: other - fill in complaints explanation.Reportable: no.Incident date: (b)(6) 1980.Hospital complaint reference #: (b)(4).Details of complaint (reported issue): syringe tip broken, or the graduation on the syringe is wrong, or the graduation is missing.We also found a hair in a sterile syringe tray.Per customer.
Additional Manufacturer Narrative
Investigation results: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 4 physical samples submitted for evaluation.The reported issue of tip breakage was not confirmed upon inspection of the samples.Analysis of the sample showed that one syringe barrel scale marking was skewed another sample has the syringe barrel scale marking missing and the other samples had no defects or imperfections detected.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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.Our quality engineer inspected the 4 physical samples submitted for evaluation.The reported issue of scale marking issue was confirmed upon inspection of the samples.Analysis of the sample showed that one syringe has the syringe barrel scale marking skewed another sample has the syringe barrel scale marking missing there are no defects or imperfections found on the other samples.Bd determined that the cause of the failure was possibly a jam occurred at the scale marking process step.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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.

• Brand Name: BD SYRINGE 20ML 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: 21293874
• Report Number: 9610847-2025-00014
• Device Sequence Number: 15397554
• Product Code: FMF
• UDI-Device Identifier: 00382903056170
• UDI-Public: (01)00382903056170(11)240911(17)290831(10)4242570
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2025

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: 305617
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 04/10/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/24/2025; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown