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

Catalog Number 306595

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation results: summary: six samples were returned to bd for evaluation.A quality engineer inspected the returned samples and determined that five of them had barrel/flange damage thus verifying the reported issue.One sample appeared to not have any visual flange/barrel damage and was tested for leaking.It passed the leak test, therefore, bd was unable to verify the defect of leakage.The cause of the barrel/flange damaged was determined to be a variation with the plunger rod labeler.The engineer inspected the equipment and made any necessary adjustments.A device history review was performed on the reported lot and found zero defects or quality notifications recorded during this production run.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Conclusion: dhr/bhr review there were no documented issues for the complaint of batch 7241671 during this production run.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Update may 9, 2018.Six (6) samples were received.None have the packaging flow wrap.All of them have the plunger rod- rubber stopper, four (4) have tip cap, all have no saline solution, the barrel labels confirm the lot# 7241671.Five (5) of them have the barrel flange damaged.Product within specification? yes? no? root cause: 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 was no issue documented about barrel/flange damaged.Root cause.The plunger rod labeler equipment possible experienced a variation; anyway, adjustments have been verified.Capa not required for this event.

Event Description

It was reported a nurse found the flange broken on a bd posiflush¿ normal saline syringe when opening the plastic package.The device functioned properly but "hurt the finger's skin" of the nurse.There was no report of exposure, serious 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
• 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: 7530603
• MDR Text Key: 109057942
• Report Number: 1911916-2018-00208
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• 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: 306595
• Device Lot Number: 7241671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• 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