MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem Eye Injury (1845)

Event Date 12/05/2019

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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use of the unspecified bd syringe a piece of plastic from the conus of syringe fired and hit nurse¿s eye.It injured eye cornea of nurse and he is on sick leave.The following information was provided by the initial reporter: it was reported that bd discardit syringe injured hcp (nurse).A piece of plastic from the conus of syringe fired and hit nurse¿s eye.It injured eye cornea of nurse and he is on sick leave.

Manufacturer Narrative

H.6 investigation summary: bd was not provided with photos or samples for the investigation for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.The material used to manufacture discardit syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100% the syringes, rejecting automatically the syringes with broken parts like the tip of the barrel.Bd believes that the piece of the tip could break because of the strong conditions during the use of the product.Considering our in-coming and in-process inspection, no corrective actions are required at this time.A device history record could not be completed as no lot number was provided.H3 other text : see h.10.

Event Description

It was reported that during use of the unspecified bd syringe a piece of plastic from the conus of syringe fired and hit nurse¿s eye.It injured eye cornea of nurse and he is on sick leave.The following information was provided by the initial reporter: it was reported that bd discardit syringe injured hcp (nurse).A piece of plastic from the conus of syringe fired and hit nurse¿s eye.It injured eye cornea of nurse and he is on sick leave.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9511622
• MDR Text Key: 172716283
• Report Number: 2243072-2019-02880
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other