MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML SALINE XS

Catalog Number 306572

Device Problem Short Fill (1575)

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

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the syringe 10ml saline xs experienced an incorrect fill -less than design specifications.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 306572 batch no.: 9224747.Per email: physician preparing for line insertion opened the packaging for a sterile prefilled 10cc ns syringe.Immediately observed that the syringe contained <2cc ns.

Event Description

It was reported that the syringe 10ml saline xs experienced an incorrect fill -less than design specifications.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 306572 batch no.: 9224747.Per email: physician preparing for line insertion opened the packaging for a sterile prefilled 10cc ns syringe.Immediately observed that the syringe contained <2cc ns.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided lot number 9224747 and the review did not reveal any detected quality issues that could have contributed to this reported incident.To further investigate this issue, one picture sample was provided for evaluation by our quality engineer.Through examination of the provided picture, the syringe was observed to be incorrectly filled.Based on the returned picture alone, it is unclear what the exact cause of the incorrect fill may have been; therefore, a manufacturing related cause could not be determined for this incident.

• Brand Name: SYRINGE 10ML SALINE XS
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 9828507
• MDR Text Key: 190908822
• Report Number: 9616657-2020-00046
• Device Sequence Number: 1
• Product Code: FMF
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9224747
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other