MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE AND NEEDLE; SYRINGE WITH NEEDLE

Catalog Number UNKNOWN

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.No lot # provided.Device manufacture date: unknown.Results: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.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.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.

Event Description

It was reported that an unspecified bd syringe and needle malfunctioned after use as the consumer thought the needle was left in thigh after use.Medical intervention was needed as patient went to the er.Consumer had 1500 bill.Results are unknown.

Manufacturer Narrative

Investigation summary: dhr could not be performed as the lot number was not provided.No samples (including photos) were returned therefore the complaint could not be confirmed.The root cause is undetermined.Conclusion: based on the above, no additional investigation and no capa is required at this time.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.

• Brand Name: UNSPECIFIED BD SYRINGE AND NEEDLE
• Type of Device: SYRINGE WITH 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 ; 8015652845
• MDR Report Key: 7066644
• MDR Text Key: 93588008
• Report Number: 2243072-2017-00389
• 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,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2017
• 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