MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE FLUSH

Catalog Number 306547

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No lot# was reported so a dhr could not be performed.No root cause can be determined as no samples were received.

Event Description

It was reported with the use of the bd posiflush¿ normal saline syringe, there was an issue with luer-lok broken off.There was no report of injury or medical intervention.

Manufacturer Narrative

The following fields have been changed with new information: medical device lot #: 8073953.Medical device expiration date: 2021-03-31.Device available for eval? yes.Returned on: 10/8/2018.Device returned to manufacturer?: yes.Device eval by manufacturer?: yes.Device manufacture date: 2018-03-14.Investigation: one sample was received with no sealed packaging flow wrap.It has the plunger rod-rubber stopper, a three way connection instead of the original tip cap and no saline solution.The barrel label confirms the lot# 8073953, and the rubber stopper is all the way to the bottom.The syringe was removed from the three way connection confirming that the luer tip got broken and now it is in the three way connection therefore failure mode is verified.The failure was reproduced by using a new syringe from the production line and connecting it to the three way connection and by screwing it all the way down and tight and the luer tip got broken.To get a good connection the three way device don¿t need to screwed all the way down and tight.This induce this failure mode.There was no documentation of issues for the complaint of batch 8073953 during this production run.

Event Description

It was reported with the use of the bd posiflush¿ normal saline syringe there was an issue with luer-lok broken off.There was no report of injury or medical intervention.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7914132
• MDR Text Key: 122195367
• Report Number: 1911916-2018-00541
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

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: 03/31/2021
• Device Catalogue Number: 306547
• Device Lot Number: 8073953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other