MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE

Model Number 300912

Device Problem Volume Accuracy Problem (1675)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0126665, medical device expiration date: 2025-04-30, device manufacture date: (b)(6) 2020.Medical device lot #: 0126661, medical device expiration date: 2025-04-30, device manufacture date: (b)(6) 2020.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 that 0.2 ml of medication remained in the bd luer-lok¿ tip syringe after the infusion when used with the b.Braun perfusor space pump.This occurred once each in lots 0126665 and 0126661.The following information was provided by the initial reporter: "0,2 ml of drug remains in syringe after infusion when used with b.Braun syringe pump the complaint is regarding remains of drug equivalent to about 0,2 ml after finalized infusion using b.Braun perfusor space pump.".

Manufacturer Narrative

H6: investigation summary: physical samples are required to perform volumetric accuracy testing to confirm the defect and determine if the problem observed by the customer is tied to the syringe and not the pump.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided lots number that could have contributed to the reported defect.H3 other text : see h10.

Event Description

It was reported that 0.2 ml of medication remained in the bd luer-lok¿ tip syringe after the infusion when used with the b.Braun perfusor space pump.This occurred once each in lots 0126665 and 0126661.The following information was provided by the initial reporter: "0,2 ml of drug remains in syringe after infusion when used with b.Braun syringe pump.The complaint is regarding remains of drug equivalent to about 0,2 ml after finalized infusion using b.Braun perfusor space pump.".

• Brand Name: BD LUER-LOK¿ TIP 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: 12312611
• MDR Text Key: 266188824
• Report Number: 1213809-2021-00561
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: 30382903009122
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 300912
• Device Catalogue Number: 300912
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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