MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD HYPO SYRINGE

Catalog Number UNKNOWN

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: 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.Device manufacture date: unknown.(b)(4).Investigation summary: as no physical sample, picture sample, material number or batch number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.As neither a material number nor a batch number are known for this incident, a device history record review could not be completed.Investigation conclusion: complaints received for this reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Root cause description: based on the limited investigation results, a cause for the reported incident could not be determined.

Event Description

It was reported that the patient had an allergic reaction after using unspecified bd¿ hypo syringe.The following information was provided by the initial reporter: the patient did not have any physical discomfort to prevent inoculation of the quadrivalent influenza virus split vaccine in their center.On the afternoon of the day after the vaccination, a hard nodule with a diameter of 3cm was found at the vaccination site, and there were no obvious abnormalities.His family came to our center the next morning consultation, asked to use a hot towel to compress, 3 days later, a telephone interview, she complained that the above discomfort has been cured.

• Brand Name: UNSPECIFIED BD HYPO SYRINGE
• Type of Device: 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 ; 8015296192
• MDR Report Key: 10900190
• MDR Text Key: 218258191
• Report Number: 2243072-2020-01930
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• 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): Other