MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRASAFE¿ PLUS X100L; SYRINGE

Catalog Number 47513302

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: unconfirmed, no sample provided.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.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.

Event Description

It was reported that the bd ultrasafe¿ plus x100l plunger came loose and leaked medication in the box.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD ULTRASAFE¿ PLUS X100L
• Type of Device: SYRINGE
• 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 ; 8015652845
• MDR Report Key: 7980499
• MDR Text Key: 124566845
• Report Number: 3001741852-2018-00020
• Device Sequence Number: 1
• Product Code: FMF
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/17/2022
• Device Catalogue Number: 47513302
• Device Lot Number: 9549052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• 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