MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LS 200 S/C; PISTON SYRINGE

Catalog Number 309659

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.(b)(6) has been used as a default.The initial reporter also notified the fda on (b)(6) 2021.Medwatch report # mw5103138.Report source other: medwatch report.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Furthermore, 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.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: no root cause can be determined as no samples were received.Rationale: capa not required at this time.

Event Description

It was reported that syringe 1ml ls 200 s/c and needle separated.The following information was provided by the initial reporter: it was reported that the tuberculin 1ml slip tip syringe would not keep the hub of 30gauge x1/2in bd needle on, when trying to remove the cap the whole needle came off the slip tip.It was also reported that the friction for the hub of the needle to the syringe was lacking.

• Brand Name: SYRINGE 1ML LS 200 S/C
• 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: 12519097
• MDR Text Key: 272906030
• Report Number: 1213809-2021-00650
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096596
• UDI-Public: 00382903096596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309659
• Device Lot Number: 1090660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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