MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRASAFE PLUS X100L; NEEDLE GUARD

Catalog Number 47513302

Device Problem Failure to Deliver (2338)

Patient Problem Missed Dose (2561)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: unconfirmed, no issue observed.Investigation conclusion: based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer but not correlate this symptom with a potential cause linked to bd process.Root cause description: customer does not require an investigation.Investigation carried out at customer site indicates that there were no abnormalities with the product detected.8d report is not required at this time.Batch record review did not indicate of any incident in relation to the problem statement.Batch was released in accordance to the acceptable criteria.Customer verbatim is not clear on the issue observed.

Event Description

It was reported that during use of the bd ultrasafe¿ plus x100l the plunger popped up when taking the product out of the package.When administering the injection a piece fell out and the needle did not come out, but patient felt liquid go down his leg.The following information was provided by the initial reporter: when he went to pull the medication out of the package the plunger popped up and he heard it click.The patient stated that he tried to administer the injection in his leg and he then felt fluid going down his leg, and the needle never came out.The patient stated that he went to pull back off leg the little case that retracts when done the whole piece fell out.

• Brand Name: BD ULTRASAFE PLUS X100L
• Type of Device: NEEDLE GUARD
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• Manufacturer (Section G): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9124698
• MDR Text Key: 191316559
• Report Number: 3001741852-2019-00057
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2023
• Device Catalogue Number: 47513302
• Device Lot Number: 1753135
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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