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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
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 had foreign matter it was reported by customer that the syringe is yellow and have a residue verbatim#: rcc received a complaint via phone.Pir attached.305618 lot 317920082 the syringe are yellow and have a residue, would like to know if they are still safe to use.Before use has samples available for the investigation.Customer would like replacements.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 10 samples submitted for evaluation.The reported issue of discoloration was confirmed upon inspection of the samples.Analysis of the samples showed that 7 of the plunger rods have a light discoloration, which is an acceptable imperfection.The reported issue of foreign matter was confirmed upon inspection of the samples.Analysis of the samples showed that the material inside the tray (cardboard) can be produced during the packaging process.A review of our risk management documentation was performed and indicates that the potential risk of the reported events 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: 19910239
• Report Number: 9610847-2024-00218
• Device Sequence Number: 15621664
• Product Code: FMF
• UDI-Device Identifier: 00382903056187
• UDI-Public: (01)00382903056187
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/22/2024

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: 3179282
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/29/2024
• 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