MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ LUER SLIP SYRINGE STERILE, 20 ML; PISTON SYRINGE

Model Number	302831
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd¿ luer slip syringe sterile, 20 ml the plunger is difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: all syringes are new not used on patients.3) complaints on syringe tightness and not smooth.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 21-feb-2023.H6.Investigation summary: it was reported the syringe is tight and not smooth when giving medication.To aid in the investigation, one sample with no packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, per it16 and the result was within specification.The photo provided shows two syringes with a drug.One is labeled as bd and the other one as terumo.No other information could be obtained from the photo.A device history record review was completed for provided material number 302831, lot number 2125533.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.
Event or Problem Description
It was reported while using bd¿ luer slip syringe sterile, 20 ml the plunger is difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: all syringes are new not used on patients.3) complaints on syringe tightness and not smooth.
Additional Manufacturer Narrative
H6: investigation summary it was reported the syringe is tight and not smooth when giving medication.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two syringe with a drug.One is labeled as bd and the other one as terumo.No other information could be obtained from the photo.A device history record review was completed for provided material number 302831, lot number 2125533.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed, and without the physical sample analysis a probable root cause could not be offered.
Event or Problem Description
It was reported while using bd¿ luer slip syringe sterile, 20 ml the plunger is difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: all syringes are new not used on patients.3) complaints on syringe tightness and not smooth.

• Brand Name: BD¿ LUER SLIP SYRINGE STERILE, 20 ML
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16090873
• Report Number: 1911916-2022-00787
• Device Sequence Number: 16646533
• Product Code: FMF
• UDI-Device Identifier: 30382903028314
• UDI-Public: (01)30382903028314
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2023

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: Other
• Device Model Number: 302831
• Device Catalogue Number: 302831
• Device Lot Number: 2125533
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 01/26/2023; 02/22/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/13/2023; 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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