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 Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 particulate was observed within the fluid path of bd syringes.Verbatim: rcc received a complaint via email.Email(s) attached.Particulate was observed within the fluid path of bd syringes.The following extrinsic particles were identified via fourier transform infrared spectroscopy (ftir): paper.(cellulose) cotton-rayon.Olefin-nylon.
Event or Problem Description
Material #: 305618, batch#: 2334749.It was reported by customer that the particulate was observed within the fluid path of bd syringes.Verbatim: rcc received a complaint via email.Email(s).Particulate was observed within the fluid path of bd syringes.The following extrinsic particles were identified via fourier transform infrared spectroscopy (ftir): ¿ paper (cellulose) (bd part # 309680).¿ cotton-rayon (bd part # 305618 and 309680).¿ olefin-nylon (bd part # 309680).Customer response for follow-up: i apologize, i missed the questions in your original email, please see the responses to your questions below: 1.Please provide the date of events for mentioned lots.¿ 3333380 (bd part # 309680) was observed on 12-mar-24.¿ 4008857 (bd part # 309680) was observed on 27-mar-24.¿ 2334749 (bd part # 305618) was observed on 27-mar-24.2.Was the issue identified before use on patient or during the use? the issue was identified and quarantined prior to use on a patient.3.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? there has not been any patient impact, the product has not been used on a patient.4.Confirm the number of quantities affected.¿ 3333380 (bd part # 309680) quantity affected: (b)(4), ¿ 4008857 (bd part # 309680) quantity affected: (b)(4), ¿ 2334749 (bd part # 305618) quantity affected: (b)(4).
Additional Manufacturer Narrative
Our quality engineer inspected the 4 photos submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the photos.In the photos foreign material can be observed on or in the sample.It was unclear as to whether the foreign material was within the body of the syringe or not.Bd cannot confirm the cause of the failure since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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: 19391908
• Report Number: 9610847-2024-00137
• Device Sequence Number: 7799425
• Product Code: FMF
• UDI-Device Identifier: 30382903056188
• UDI-Public: (01)30382903056188
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 05/29/2024

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: 2334749
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown