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

Catalog Number UNKNOWN

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/14/2018

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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: unknown.Medical device expiration date: n/a.Device manufacture date: unknown.Investigation: 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.Without a sample, an absolute root cause for this incident cannot be determined.

Event Description

It was reported during use of an unspecified bd insulin syringe the consumer reported the needle broke off after injection, stated that the needle stayed in her arm when she removed the syringe.No lot number or product information, packaging and syringe were discarded, does not know when syringe was purchased.Broken needle had to be removed from the patient's arm by husband.There was no report of injury or medical intervention.

Manufacturer Narrative

No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.Severity: s_2__; occurrence: unable to perform complaint lot history check due to unknown lot number.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned 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.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: UNSPECIFIED BD INSULIN SYRINGE WITH NEEDLE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7314003
• MDR Text Key: 101705406
• Report Number: 2243072-2018-00099
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other