MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD® LUER SLIP TIP SYRINGE STERILE; PISTON SYRINGE

Catalog Number	309659
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plunger for the bd® luer slip tip syringe sterile was difficult to move.The following was received fromt the initial reporter: stopper is very tight.Stopper is unable to move.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the plunger for the bd® luer slip tip syringe sterile was difficult to move.The following was received fromt the initial reporter: stopper is very tight.Stopper is unable to move.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 02-oct-2023.H6: investigation summary 1,575 unopened samples were received by bd for evaluation.A quality engineer was able to review the samples of a syringe 1ml ls 200 s/c from lot # 2042937 regarding item # 309659 with the reported complaint of "plunger movement difficult".The samples were evaluated for functionality and lubricant presence via exercising the plunger rod.All samples were observed to have some level of lubricant present and were functional, with the plunger/stopper gliding along the barrel with little to no resistance.The syringes received were acceptable per product specification.A root cause was unable to be determined.No corrective action is required at this time.A device history record review was completed for provided batch number 2042937.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch #2042937 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.

• Brand Name: BD® LUER SLIP TIP SYRINGE STERILE
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17857926
• Report Number: 1213809-2023-01086
• Device Sequence Number: 6073219
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: (01)30382903096597
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 10/09/2023

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: 309659
• Device Lot Number: 2042937
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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