MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD LUER-LOK¿ SYRINGE; PISTON SYRINGE

Catalog Number 309702

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd luer-lok¿ syringe experienced leakage.The following information was provided by the initial reporter: re-fill syringes with drug solution for nursing staff to administer for patients and we have noticed that the syringes are leaking.Syringes leaking in pharmacy are caught and disposed of but if anything leaks after it has been dispensed to nursing staff it¿s possible that the sterility of the syringe is contaminated and the patient will not get their full dose.

Event Description

It was reported that the bd luer-lok¿ syringe experienced leakage.The following information was provided by the initial reporter: re-fill syringes with drug solution for nursing staff to administer for patients and we have noticed that the syringes are leaking.Syringes leaking in pharmacy are caught and disposed of but if anything leaks after it has been dispensed to nursing staff it¿s possible that the sterility of the syringe is contaminated and the patient will not get their full dose.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of leakage was confirmed upon inspection of the photo.From the provided photo it was observed that the unknown medication was leaking beyond the rib of the stopper.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Examination of the actual product involved may provide clarification as to the cause of the reported failure.Dhr for this lot was reviewed and there are no internal rejects related to the reported issue by the customer.According to the quality records all the inspections of the sampling plan met the acceptance criteria.H3 other text : see h10.

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17475393
• MDR Text Key: 320878293
• Report Number: 1920898-2023-00527
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903097029
• UDI-Public: 00382903097029
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309702
• Device Lot Number: 2248603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1