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

Model Number	309701
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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.
Event or Problem Description
It was reported that a hole in the paper packaging of the bd luer-lok¿ syringe bulk sterile pharmacy convenience tray left the product unsterile.The following information was provided by the initial reporter: "a package of 1ml syringes arrived with a hole in the paper cover of the tray.The product is no longer sterile.".
Event or Problem Description
It was reported that a hole in the paper packaging of the bd luer-lok¿ syringe bulk sterile pharmacy convenience tray left the product unsterile.The following information was provided by the initial reporter: "a package of 1ml syringes arrived with a hole in the paper cover of the tray.The product is no longer sterile.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 30-jun-2022.H.6.Investigation summary: our quality engineer inspected the 1 picture and 1 sample submitted for evaluation.The reported issue of package damaged / defective / other was confirmed upon inspection of the sample.However, bd was unable to confirm that the defect was caused by our manufacturing processes.All processes were analyzed, and none were able to reproduce the failure.An awareness notification was sent to all manufacturing personnel involved in the packaging process to increase awareness.A retraining was also performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
• Common Device Name: 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: 14835642
• Report Number: 9610847-2022-00236
• Device Sequence Number: 2350865
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2025
• Device Model Number: 309701
• Device Catalogue Number: 309701
• Device Lot Number: 2004255
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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