MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 5 ML BD POSIFLUSH¿ SP

Catalog Number 306574

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

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 and/or device history review, a supplemental report will be filed.

Event Description

It was reported that there was difficult plunger movement when using a 5 ml bd posiflush¿ sp.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

No samples displaying the condition reported are available for examination.Bd is unable to fully investigate this incident.No root cause can be determined as no samples were received.There was no documentation of issues for the complaint of batch 7264801 during this production run.This is the first complaint for the lot# 7264801 for the same defect or symptom.Investigation conclusion: possible the sustaining force was on the high side of the product spec inducing the symptom reported.

Event Description

It was reported that there was difficult plunger movement when using a 5 ml bd posiflush sp.There was no report of exposure, injury or medical intervention.

Event Description

It was reported that there was difficult plunger movement when using a 5 ml bd posiflush¿ sp.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: this is the first complaint for the lot# 7264801 for the same defect or symptom.Two (2) samples were received for evaluation by one of our quality engineers.Both have no packaging flow wrap, the plunger rod-rubber stopper, the tip cap, the saline solution.The barrel label confirms the lot# 7264801.They were tested for sustaining force; one had 12.80n and the other 13.75n; the product specification is <20n.Samples were within specification therefore failure mode is not verified.While a definitive root cause could not be determined, it is possible that the sustaining force was on the high side of the product spec inducing the symptom reported.Investigation conclusion: possible the sustaining force was on the high side of the product spec inducing the symptom reported.(product spec for sustaining force <20n).

Event Description

It was reported that there was difficult plunger movement when using a 5 ml bd posiflush¿ sp.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: unknown.Event attributed to: other.Device single use?: no.Device returned to manufacture: no.

• Brand Name: 5 ML BD POSIFLUSH¿ SP
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7599083
• MDR Text Key: 111450902
• Report Number: 1911916-2018-00297
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 306574
• Device Lot Number: 7264801
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other