MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML TB SYRINGE SLIP TIP; PISTON SYRINGE

Catalog Number 309623

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 02/01/2021

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that the bd 1ml tb syringe slip tip experienced hub separation from the device.The following information was provided by the initial reporter: material no.309623, batch no.0021463.Consumer reported difficulty removing the needle shields on some of her syringes.Stated she has arthritis and sometimes she can't remove the shields at all.Stated other times the whole needle component comes off with the shield.Consumer stated today she tried to use a butter knife to remove the needle shield and she ended up poking herself with the needle.No injury reported.

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 that the bd 1ml tb syringe slip tip experienced hub separation from the device.The following information was provided by the initial reporter: material no.309623 batch no.0021463.Consumer reported difficulty removing the needle shields on some of her syringes.Stated she has arthritis and sometimes she can't remove the shields at all.Stated other times the whole needle component comes off with the shield.Consumer stated today she tried to use a butter knife to remove the needle shield and she ended up poking herself with the needle.No injury reported.

• Brand Name: BD 1ML TB SYRINGE SLIP TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11382617
• MDR Text Key: 233787197
• Report Number: 1213809-2021-00108
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309623
• Device Lot Number: 0021463
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1