MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY, 3 ML; PISTON SYRINGE

Model Number 309702

Device Problem Leak/Splash (1354)

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

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported by the customer that during use of the, bd luer-lok syringe bulk sterile pharmacy convenience tray, 3 ml, a leakage occurred due to stopper angularity.The following information was provided by the initial reporter: "material no: unknown.Batch no: unknown.It was reported by the customer a leakage.Verbatim: the customer has specified that leakage has occurred due to stopper angularity.".

Manufacturer Narrative

The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: since no photos or samples displaying the reported condition of leakage at adapter were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported by the customer that during use of the, bd luer-lok¿ syringe bulk sterile pharmacy convenience tray, 3 ml, a leakage occurred due to stopper angularity.The following information was provided by the initial reporter: "material no: unknown; batch no: unknown.It was reported by the customer a leakage.Verbatim: the customer has specified that leakage has occurred due to stopper angularity.".

• Brand Name: BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY, 3 ML
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14777253
• MDR Text Key: 302501797
• Report Number: 9610847-2022-00228
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903097020
• UDI-Public: 30382903097020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309702
• Device Catalogue Number: 309702
• Device Lot Number: 1148006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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