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

Catalog Number 306546

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 with the use of the bd posiflush¿ normal saline syringe there was an issue with a damaged device.It was stated ¿a nurse who was working in a home setting: that when drawing back the plunger, the plunger came completely out of the syringe.No samples are available and no replacements were required.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.

Event Description

It was reported with the use of the bd posiflush¿ normal saline syringe there was an issue with a damaged device.It was stated ¿a nurse who was working in a home setting: that when drawing back the plunger, the plunger came completely out of the syringe.No samples are available and no replacements were required.¿ there was no report of injury or further 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: 7620633
• MDR Text Key: 112191209
• Report Number: 1911916-2018-00323
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

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: Nurse
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8050999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other