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

Catalog Number 301073

Device Problem Missing Information (4053)

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

Event Date 09/07/2023

Event Type  malfunction  

Event Description

It was reported that the box of bd luer-lok¿ syringes had no label on it.The following information was provided by the initial reporter: "customer received 1 bx of pcn 301073 without any labels.".

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

No additional information was provided.

Manufacturer Narrative

One batch of 500 samples were received by bd for evaluation.A quality engineer was able to review the samples of a syringe 3ml ll bns from unknown lot regarding item #301073 with the reported complaint of ¿label content missing¿.The samples were examined, and the reported issue was confirmed.No labeling could be found nor was the batch information able to be identified.Packaging of the bulk non-sterile product is a manual process.An operator must manually weigh and label each box.It is likely that the operator overlooked labeling the case in question.Risk to patient safety is low.A device history record review was not completed due to the batch number being unknown.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no corrective and preventative actions (capa)/situation analysis (sa) is required at this time.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17804205
• MDR Text Key: 324123552
• Report Number: 1920898-2023-00647
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

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
• Device Operator: Other
• Device Catalogue Number: 301073
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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