MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 5ML SALINE FILL; SALINE SYRINGE

Catalog Number 306594

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H3 other text : see.H.10.

Event Description

It was reported that a missing cap tip was found before use with a syringe 5ml saline fill.The following information was provided by the initial reporter, "before use, the customer found the tip cap was missing.".

Manufacturer Narrative

Investigation summary: one samples were received with a missing tip cap, therefore failure mode is verified.The sample was taken to the line and the sensor was challenged.It rejected the sample.The sensor is challenged at the beginning of each shift.While a definitive root cause could not be determined, an issue with the filling machine can cause this issue.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported that a missing cap tip was found before use with a syringe 5ml saline fill.The following information was provided by the initial reporter, "before use, the customer found the tip cap was missing.".

• Brand Name: SYRINGE 5ML SALINE FILL
• Type of Device: SALINE SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8805274
• MDR Text Key: 151734392
• Report Number: 1911916-2019-00721
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903065943
• UDI-Public: 382903065943
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 306594
• Device Lot Number: 8261843
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other