MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED SYRINGES

Catalog Number UNKNOWN

Device Problem Difficult to Remove (1528)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/28/2019

Event Type  Injury  

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.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.Investigation conclusion: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.Root cause description: undetermined.Rationale: no batch#/sample available.

Event Description

Material no.Unknown, batch no.Unknown.It was reported the customer had trouble removing the syringe cap and had a needle stick.The date/time and or patient information is unknown.¿ the following information was provided by the initial reporter: "a report was received 17may2019 via med info.Received a call on 17 may2019 warm transferred from shire ae line, with onboarding access specialist reporting an ae/pqc for gattex.The caller states: 'i had a call today from a patient who is having problems getting the cap off of the diluent (for gattex) today she said some of the diluent caps are more difficult than others to get off.She reported she had a needle stick as well today.The patient stated her does today was delayed due to this problem and she will try again later on with other bottles of the diluent she has in her supply.The patient would like more training with this from a nurse and i will be contacting one path to assist with her.' the caller states it is unknown if product has been retained by patient for potential return.(b)(6) on 24may2019- called patient.She reported she actually had trouble removing the syringe cap from the syringe she uses to inject the medicine.She keeps the needle straight and pulls cap off straight.Now uses her thumb to remove cap so she doesn't jab herself anymore.She reported this to medinfo already.Provided a kit lot number av19094aa and said it happened with a previous kit as well.This record will be updated accordingly and a record for a no lot will be added.".

• Brand Name: UNSPECIFIED SYRINGES
• 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 ; 8015652341
• MDR Report Key: 8662897
• MDR Text Key: 146913475
• Report Number: 2243072-2019-01072
• 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: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• 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: 05/28/2019
• 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