MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

Catalog Number 306547

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: this is the first complaint to the batch 7146913 for the same defect or symptom.There were no documentation issues for this complaint during the production run for batch 7146913.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Update sep27, 2017.A sample was received.It is in ziploc plastic bag.The barrel label confirms the lot# 7146913.It doesn¿t have tip cap.The plunger rod- stopper is all the way down; therefore, it is empty (no saline solution).The visual inspection didn¿t show any fm, then the plunger rod-stopper was removed not finding any fm; inside the barrel was inspected under the microscope looking for any type of fm with no success.The plastic bag where the syringe came in was also inspected looking for any type of fm that may be loose inside the bag finding nothing; the plastic bag was also inspected under the microscope, finding no fm.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 issues documented about any type of foreign matter.We will wait for the sample to further investigate this complaint.Update sep27, 2017.The sample received doesn¿t have any fm; root cause couldn¿t be determined.Investigation conclusion: investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Update sep27, 2017.A sample was received.It is in ziploc plastic bag.The barrel label confirms the lot# 7146913.It doesn¿t have tip cap.The plunger rod- stopper is all the way down; therefore, it is empty (no saline solution).The visual inspection didn¿t show any fm, then the plunger rod-stopper was removed not finding any fm; inside the barrel was inspected under the microscope looking for any type of fm with no success.The plastic bag where the syringe came in was also inspected looking for any type of fm that may be loose inside the bag finding nothing; the plastic bag was also inspected under the microscope, finding no fm.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 issues documented about any type of foreign matter.We will wait for the sample to further investigate this complaint.Update sep27, 2017.The sample received doesn¿t have any fm; root cause couldn¿t be determined.(b)(4).

Event Description

This complaint is mdr reportable.It was reported the plunger rod of a 10 ml bd posiflush¿ normal saline syringe was having difficulty moving due to resistance.As the nurse observed the syringe / plunger, she found a needle in the syringe.This was observed before use.No injury or medical intervention.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 6909108
• MDR Text Key: 88158215
• Report Number: 1911916-2017-00259
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 306547
• Device Lot Number: 7146913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• 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