MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 the consumer stuck herself on the unspecified bd syringe with needle during use after giving her pet an injection and attempting to re-shield the device.The following information was provided by the initial reporter: pet owner reported sticking her finger when she re-shield after giving pet injection.Pet owner re-shields.Stated: did not know she should not re-shield.Stated: there was bleeding but it stopped soon after.No medical attention received.Does not plan on seeking medical or re-shielding going forward.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr review due to unknown lot number.As no samples and/or photo(s) were received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported that the consumer stuck herself on the unspecified bd¿ syringe with needle during use after giving her pet an injection and attempting to re-shield the device.The following information was provided by the initial reporter: pet owner reported sticking her finger when she re-shield after giving pet injection.Pet owner re-shields.Stated: did not know she should not re-shield.Stated: there was bleeding but it stopped soon after.No medical attention received.Does not plan on seeking medical or re-shielding going forward.

• Brand Name: UNSPECIFIED BD SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8879130
• MDR Text Key: 153835538
• Report Number: 2243072-2019-01650
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other