MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ MINI PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320522

Device Problem Break (1069)

Patient Problems Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date : unknown.Medical device manufacture date : unknown.Investigation summary : exec summary - no samples (including photos) were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined.Unable to perform complaint lot history check owing to an unknown lot number for this event.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - no dhr review can be carried out as the lot number is unknown.

Event Description

It was reported that 1 bd ultra-fine¿ mini pen needle cannula broke off.The following information was provided by the initial reporter : it was reported on behalf of the patient that the needle had broken off and could not be found even by the doctor who then assumed the broken needle was not in the patient.The skin at the injection site had become inflamed.The patient also uses each needle several times.And also uses each needle several times.

• Brand Name: BD ULTRA-FINE¿ MINI PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12837285
• MDR Text Key: 282985378
• Report Number: 9616656-2021-01426
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320522
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• 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): Hospitalization