MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED PEN NEEDLE

Catalog Number UNKNOWN

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 04/04/2019

Event Type  malfunction  

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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field medical device expiration date: unknown.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 unknown lot number for needle bending during use, harm bleeding & harm injury.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

Material no.Unknown, batch no.Unknown.It was reported that during use of the unspecified pen needle the needles are bending during use.It was also reported that consumer experienced site injury and bleeding.The following information was provided by the initial reporter: verbatim: medical history and concomitant medications were not provided.Patient received teriparatide (forteo), unknown dose, frequency, route of administration, indication of use and start date.On unknown date, unspecified time after starting teriparatide therapy, patient received bent needles (5mm, becton dickinson) with teriparatide.Patient only noticed that the needles were bend after she tried to inject the medication on unknown date.Patient experienced injection site injury and bleeding.As corrective treatment a cotton with alcohol was placed at the injection site.Laboratory examinations were not provided.Status of teriparatide therapy was not provided.Outcome for the adverse events was unknown.Patient operated the device.It was unknown if operator was trained and how long the patient has been using this device model.Return of device was not expected.The consumer reporter did not relate the event to teriparatide or the device.The events were related to the needles.

• Brand Name: UNSPECIFIED PEN NEEDLE
• Type of Device: PEN NEEDLE
• 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 ; 8015652341
• MDR Report Key: 8551745
• MDR Text Key: 147611133
• Report Number: 2243072-2019-00788
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• 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