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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
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 30ml ll tip conv pak leaked it was reported by customer that multiple syringes are leaking.Verbatim: hello, we have received the below product problem report.Stevens ref#(b)(4) has been assigned to this issue.Upon completion, please provide a quality investigation letter detailing your findings.Please advise on next steps for quality investigation and customer resolution: product problem report product information product code: 305618 product description: syringe hypo 30cc l/l conv.Pk bulk ster ca/120 p36 lot/serial #: (b)(6) expiry date: 2028-06-30 problem information multiple syringes are leaking.Occurrences: recurring - customer has not tracked reporter information reporter name: xxxx reporter position/department: clinical value analysis reporter phone: xxxx reporter email: xxxx site information xxxx sample information incident samples: 0 representative samples: 2 case (240 ea) no adverse event reported.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 5 trays and 1 photo submitted for evaluation.The reported issue of leakage was not confirmed upon inspection of the samples.Analysis of the sample showed that no leak 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 this batch meets our manufacturing specification requirements.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 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: 20418299
• Report Number: 9610847-2024-00307
• Device Sequence Number: 8613033
• Product Code: FMF
• UDI-Device Identifier: 00382903056187
• UDI-Public: (01)00382903056187(11)230803(17)280630(10)3195679
• 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
• Report Date (Section B): 01/15/2025

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: 305618
• Device Lot Number: 3195679
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown