MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSULIN SYRINGE

Catalog Number UNKNOWN

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

Patient Problem No Code Available (3191)

Event Date 05/01/2016

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) has been used for the manufacture report number.The incident occurred in (b)(6) 2016.Results: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number for this incident was not provided.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that in (b)(6) 2016, an unspecified bd insulin syringe was used by a patient's physician, dr.(b)(6), for an intraocular avastin injection to treat wet macular degeneration.After the procedure the patient noticed a number of small black spots in his field of vision.The patient noticed that the black spots remained constant throughout the summer and received two more treatments by another physician at (b)(6).The patient followed up with dr.(b)(6) in (b)(6) for additional treatment and mentioned the black spots to him.The patient was assured there was no danger from this and in all likelihood would dissipate with time.However, the patient states that he still has the black spots and they are nor dissipating.No medical interventions to treat the patient's affected vision were reported.

• Brand Name: UNSPECIFIED BD INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6196846
• MDR Text Key: 63065643
• Report Number: 2243072-2016-00051
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Disability
• Patient Age: 81 YR