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

Catalog Number 30654778

Device Problem Leak/Splash (1354)

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

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd¿ syringe leaked past the barrel during use.This occurred on 2 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "these actually leaked pass the barrel, i noticed this when my orientee handed them to me at a bedside.".

Manufacturer Narrative

Correction: the catalog and lot numbers have been provided.The following fields have been updated: b.5.Describe event or problem: it was reported that medication leaked past the bd posiflush¿ normal saline flush syringe stopper during use.Lot#'s 9056671, 9017637, and an unspecified lot were reported to have been involved in this event, but it is unknown how many occurrences happened within each.The following information was provided by the initial reporter: "these actually leaked pass the barrel, i noticed this when my orientee handed them to me at a bedside." d.1.Medical device brand name: bd posiflush¿ normal saline flush syringe, d.2.Medical device catalog#: 30654778, d.2.Common device name: saline vascular access flush and d.2.Medical device type: ngt.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 9056671, d.4.Medical device expiration date: 2022-02-28 and h.4.Device manufacture date: 2019-02-25.D.4.Medical device lot #: 9017637, d.4.Medical device expiration date: 2022-01-31 and h.4.Device manufacture date: 2019-01-17.D.4.Medical device lot #: unknown, d.4.Medical device expiration date: unknown and h.4.Device manufacture date: unknown.D.3.Medical device manufacturer: bd medical (bd west) medical surgical.D.5.Unique identifier (udi) #: (b)(4).G.2.Manufacturing location: bd medical (bd west) medical surgical.G.5.Pma / 510(k)#: k161552.

Event Description

It was reported that medication leaked past the bd posiflush¿ normal saline flush syringe stopper during use.Lot#'s 9056671, 9017637, and an unspecified lot were reported to have been involved in this event, but it is unknown how many occurrences happened within each.The following information was provided by the initial reporter: "these actually leaked pass the barrel, i noticed this when my orientee handed them to me at a bedside.".

Manufacturer Narrative

H.6.Investigation summary: four sample were received.They are contaminated with blood past the rubber stopper.Additionally, two photos were provided.They show the syringes with blood that past the rubber stopper.The syringes are not designed to draw blood.They are designed to flush the iv line by pressing the plunger rod down, never to be pulled up.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.H3 other text : see section h.10.

Event Description

It was reported that medication leaked past the bd posiflush¿ normal saline flush syringe stopper during use.Lot#'s 9056671, 9017637, and an unspecified lot were reported to have been involved in this event, but it is unknown how many occurrences happened within each.The following information was provided by the initial reporter: "these actually leaked pass the barrel, i noticed this when my orientee handed them to me at a bedside.".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE FLUSH SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9504015
• MDR Text Key: 177855827
• Report Number: 2243072-2019-02870
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2020

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: Health Professional
• Device Catalogue Number: 30654778
• Device Lot Number: SEE SECTION H.10.
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/05/2019; 12/05/2019
• Supplement Dates FDA Received: 01/03/2020; 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other