MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE 1ML ST BULK CONVENIENCE PAK

Catalog Number	309701
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
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 1ml st bulk convenience pak leaked the following information was provided by the initial reporter: it was reported by consumer that we are currently experiencing multiple leaking syringes with two lot numbers: (b)(6) exp: 2027-09-30 and (b)(6) exp: 2027-10-31.Verbatim: rcc received a complaint via email.Email(s) attached.Member: (b)(4).Vendor: becton dickinson (bd) canada inc.Product: syringe, iv, sterile, 1 ml, pharmacy bulk tray province: (b)(6) lot number: 3212533 expiry: 2027-10-31 problem description: we are currently experiencing multiple leaking syringes with two lot numbers: (b)(6) exp: 2027-09-30 and (b)(6) exp: 2027-10-31.
Additional Manufacturer Narrative
Our quality engineer inspected the 28 samples submitted for evaluation.The reported issue of leakage other was not confirmed upon inspection and testing of the samples.Analysis of the sample showed that there were no abnormalities or defects present.The samples were tested, and no leakage was observed.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.Production records were reviewed, and these batches meet 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.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 1ML ST 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: 18705377
• Report Number: 9610847-2024-00030
• Device Sequence Number: 6234809
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: (01)30382903097013
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: 309701
• Device Lot Number: 3212533
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/15/2024
• 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