MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE FLUSH

Catalog Number 306547

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a sample was received for evaluation.It came in a biohazard plastic ziploc bag.It has the plunger rod-rubber stopper.The saline solution is up to the 7ml mark scale and it has no tip cap.The barrel label confirms the lot# 7297648.The tip is damaged therefore failure mode if verified.It shows the tip was exposed to excessive force.It would have been helpful to analyze the component where the syringe was connected to better understand how the damage occurred.Root cause could not be determined.There were no quality notifications issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.A device history review indicated that there were no documented issues for the complaint of batch 7297648 during this production run.Investigation conclusion: investigation comments: all our inspections performed while manufacturing this batch were accepted.No rejections were documented.On (b)(6) 2018 a sample was received.It came in a biohazard plastic ziploc bag.It has the plunger rod-rubber stopper, the saline solution is up to the 7ml mark scale, it has no tip cap.The barrel label confirms the lot# 7297648.The tip is damaged.It shows the tip was exposed to excessive force.It would have been helpful to analyze the component where the syringe was connected to better understand how the damage occurred.Product within specification? yes / no.Root cause description: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There were no parts damaged documented.Rationale: capa not required for this event.

Event Description

It was reported that the bd posiflush¿ normal saline syringe broke off in arterial line transducer.No reports of serious injury.Happens when the nurses are monitoring blood pressure.When they have to zero out the line, they hook a saline syringe up to the end to keep it primed.Replaced syringe in order to continue monitor blood pressure.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7494177
• MDR Text Key: 107727105
• Report Number: 1911916-2018-00181
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 306547
• Device Lot Number: 7297648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2017
• 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