MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE; PISTON SYRINGE

Model Number 305271

Device Problem Leak/Splash (1354)

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

Event Date 10/11/2021

Event Type  malfunction  

Event Description

It was reported bd integra syringe had difficult plunger movement and leakage.The following information was provided by the initial reporter: ".The syringe stopped prematurely and leaked out.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.Unknown,(b)(6) has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.Unknown,(b)(6) has been used as a default.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 bd integra syringe had difficult plunger movement and leakage.The following information was provided by the initial reporter: ".The syringe stopped prematurely and leaked out.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.

Event Description

It was reported bd integra syringe had difficult plunger movement and leakage.The following information was provided by the initial reporter: ".The syringe stopped prematurely and leaked out.".

• Brand Name: BD INTEGRA SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12772151
• MDR Text Key: 285715973
• Report Number: 1213809-2021-00755
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: 30382903052715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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: Health Professional
• Device Model Number: 305271
• Device Catalogue Number: 305271
• Device Lot Number: 0113668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• 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