MAUDE Adverse Event Report: BECTON DICKINSON ULTRASAFE X100L PR PLUM SSL NVS STEIN; NEEDLE GUARD

Catalog Number 47513302

Device Problem Failure to Deliver (2338)

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

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: k011369, k060743, k122558.Investigation summary: unconfirmed, no sample received 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: a full root cause analysis could not be conducted with the available information and is closed without a conclusion.Until samples are available no further investigation will be carried out.Batch record review did not indicate of any incident in relation to the problem statement.Batch was released in accordance to the acceptable criteria.Complaint could potentially be related to a loose plunger.

Event Description

It was reported that the ultrasafe x100l pr plum ssl nvs stein experienced a plunger that was broken/loose/falls out prior to use.The following information was provided by the initial reporter: plunger detached from syringe.

• Brand Name: ULTRASAFE X100L PR PLUM SSL NVS STEIN
• 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: 9126069
• MDR Text Key: 191316196
• Report Number: 3001741852-2019-00059
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K011369
• 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: 09/25/2019

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: Other
• Device Expiration Date: 11/19/2022
• Device Catalogue Number: 47513302
• Device Lot Number: 1712674
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• 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