MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN.; PISTON SYRINGE

Catalog Number	309597
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd¿ luer slip tip syringe with attached needle 26 g x 5/8 in.There were volume issues.There was no report of patient impact.The following information was provided by the initial reporter: the patient stated that after injecting, medication had residual liquid in needle and she has drawn out a little extra into syringe.Pharmacist reviewed to only draw to recommended dose and the syringe/needle are calibrated to account for the medication stuck in needle.Patient stated that she was pushing syringe plunger all the way down.
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Material#:309597, batch#:2263232.It was reported by customer that the patient stated that after injecting, medication had residual liquid in needle and she has drawn out a little extra into syringe.Pharmacist reviewed to only draw to recommended dose and the syringe/needle are calibrated to account for the medication stuck in needle.Patient stated that she was pushing syringe plunger all the way down.Verbatim: notification only (takeda will utilize previous inv requested under tw (b)(4)) for pr# (b)(4) ¿ withdrawing difficulty.Bd syringe: plastic dosing syringe (1 ml) with needle attached (26g, 5/8 inch).Bd syringe lot numbers: 2263232.Takeda awareness date: 20 sep 2023.The patient stated that after injecting, medication had residual liquid in needle and she has drawn out a little extra into syringe.Pharmacist reviewed to only draw to recommended dose and the syringe/needle are calibrated to account for the medication stuck in needle.Patient stated that she was pushing syringe plunger all the way down.Product: gattex.Country of origin: united states.Sample / photo availability: no sample or photos were provided to takeda.Ae: no ae reported.Patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.No investigation due.
Additional Manufacturer Narrative
Production databases and technical logs were also reviewed as part of this investigation with no relevant findings noted related to volumetric accuracy.Volumetric accuracy testing is performed during the production of each production batch and documented in the device history record.As noted in the device history record review no qns related to volumetric accuracy were raised during this production batch.The issue described in the complaint appears to pertain to what is known as dead space.Dead space does not affect volumetric accuracy of the syringe.This product is manufactured and sold in accordance with iso 7886-1.The amount of dead space allowed for this product size is 0.07 ml.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.

• Brand Name: BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN.
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17908696
• Report Number: 1213809-2023-01115
• Device Sequence Number: 7645316
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: (01)30382903095972
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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: Other
• Device Catalogue Number: 309597
• Device Lot Number: 2263232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown