MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Retinal Injury (2048); Visual Impairment (2138); Injury (2348)

Event Date 08/21/2019

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 in and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter: address unavailable.Bd corporate address used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It has been reported that the unspecified bd¿ syringe has been found causing serious injury during use.The following has been provided by the initial reporter: material no: unknown, batch no: unknown.It was reported that the consumer encountered personal injuries to his retina accompanied by significant visual impairments that required surgery to repair.Verbatim: plaintiff treated with doctor beginning in (b)(6) 2015 and there after as a result, he suffered personal injuries to his retina accompanied by significant visual impairments that required surgery to repair.Plaintiff sustained injury to his person including, but not limited to, chronic pain, loss of visual perception and composition and damage to his retina resulting in the need for vitreous surgery and medical care.

Event Description

It has been reported that the unspecified bd¿ syringe has been found causing serious injury during use.The following has been provided by the initial reporter: material no: unknown batch no: unknown it was reported that the consumer encountered personal injuries to his retina accompanied by significant visual impairments that required surgery to repair.Verbatim: plaintiff treated with doctor beginning in (b)(6) 2015 and thereafter as a result, he suffered personal injuries to his retina accompanied by significant visual impairments that required surgery to repair.Plaintiff sustained injury to his person including, but not limited to, chronic pain, loss of visual perception and composition and damage to his retina resulting in the need for vitreous surgery and medical care.

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 check due to an unknown lot number for harm injury (ocular injection).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.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8994705
• MDR Text Key: 159226700
• Report Number: 2243072-2019-01981
• 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: other
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention