MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 30ML LL TIP CONV PAK; SYRINGE, PISTON

Catalog Number	305618
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mat#:305618 , batch#: 3150632.It was reported by the customer that they had 5 syringes that were leaking through the plunger inside the barrel (all from different packs but all the same lot).Verbatim: rcc received a complaint via phone.Pir attached.Ref (b)(4), syringe 30ml ll tip conv pak, lot 3150632.They had 5 syringes that were leaking through the plunger inside the barrel (all from different packs but all the same lot).(b)(6) 2023.Please advise the occurrence date: (b)(6) 2023.Is there any adverse event on patient? : no, leaking was observed before the syringes left the pharmacy.Is there any medical intervention needed due to the incident?: no.What is the drug used during the incident? : cefepime and ceftriaxone.Do you have photo for our review?: yes.Is sample available for return? if yes, please advise your address for return label.We have the 5 syringes that have drug in them.We also have 6 packs from the same lot that have not been opened.
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a0504 - leak / splash.
Event or Problem Description
No additional information received.Mat#:305618 batch#: 3150632.It was reported by the customer that they had 5 syringes that were leaking through the plunger inside the barrel (all from different packs but all the same lot).Verbatim: rcc received a complaint via phone.Pir attached.Ref (b)(4).Syringe 30ml ll tip conv pak.Lot 3150632.They had 5 syringes that were leaking through the plunger inside the barrel (all from different packs but all the same lot).16 oct 23.Please advise the occurrence date.(b)(6) 2023 -is there any adverse event on patient? no, leaking was observed before the syringes left the pharmacy.Is there any medical intervention needed due to the incident? no.What is the drug used during the incident? cefepime and ceftriaxone.Do you have photo for our review? yes.Is sample available for return? if yes, please advise your address for return label.We have the 5 syringes that have drug in them.We also have 6 packs from the same lot that have not been opened.
Additional Manufacturer Narrative
Our quality engineer inspected the 5 unpackaged samples submitted for evaluation.The reported issue of leakage past stopper was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that there were no discernable damages or irregularities present.The samples all underwent leakage testing, and all passed with no signs of leakage.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.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.H3 other text : see narrative below.

• Brand Name: SYRINGE 30ML LL TIP CONV PAK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales IL ; MX
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17950839
• Report Number: 1911916-2023-00779
• Device Sequence Number: 15150962
• Product Code: FMF
• UDI-Device Identifier: 30382903056188
• UDI-Public: (01)30382903056188
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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: 3150632
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown