MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Model Number 302830

Device Problem Volume Accuracy Problem (1675)

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

Event Date 01/14/2022

Event Type  malfunction  

Event Description

It was reported that bd syringe luer-lok¿ tip was missing scale markings.The following information was provided by the initial reporter: " syringe is void of any markings.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd syringe luer-lok¿ tip was missing scale markings.The following information was provided by the initial reporter: " syringe is void of any markings.".

Manufacturer Narrative

H6: investigation summary it was reported the syringe is void of any markings.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows a syringe in a plastic bag.There is a device connected to the syringe barrel luer lock and the plunger rod is all the way down.In this photo the packaging blister is next to the syringe.The syringe barrel scale is not visible on the syringe.The second photo shows the packaging blister top web.A device history record review was completed for provided material number 302830, lot number 1307334.The review revealed there was documentation for this type of defect during the production run of this batch.The barrel printing pump was found low on ink and ink was added.The affected product was segregated but this product could have been an escape while producing this lot.Verification of the printing process was done finding the settings correct.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 is confirmed.

• Brand Name: BD SYRINGE LUER-LOK¿ TIP
• Type of Device: 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: 13479848
• MDR Text Key: 286677944
• Report Number: 1911916-2022-00063
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028307
• UDI-Public: 30382903028307
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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 Model Number: 302830
• Device Catalogue Number: 302830
• Device Lot Number: 1307334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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