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

Catalog Number 306595

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a sample was received at the manufacturing plant for evaluation.The engineer observed that the stopper was half way down the syringe at the 5.5ml mark but the saline solution was only at 3.5ml.It was noted that the syringe had a crack at the 4ml mark and that it was about 4 inches long.It is reasonable to conclude that the leak was caused by this crack in the barrel.The engineer confirmed that the device was outside of specification and that the failure mode was verified.The cause of the crack couldn't be determined upon investigation and there were no quality issues found during production of this batch.A device history review was performed on the reported batch and no documented issues were found during production of the reported batch.Dhr/bhr review there was no documentation of issues for the complaint of batch 7173520 during this production run about low fill volume or saline leaking.Investigation comments: all our inspections and testing performed while manufacturing this batch were accepted.Update mar08, 2018.A sample was received.It has sealed the packaging flow wrap, it has the plunger rod-rubber stopper, the tip cap and saline.The rubber stopper is half the way down at 5.5ml.The saline solution level is at 3.5ml.There are residues of solution outside the syringe and inside the packaging flow wrap.After opening the packaging flow wrap it is noticeable a crack ~4¿ long on the barrel.It starts at the 4ml mark.The leak of the saline solution came from this barrel crack.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 and testing were accepted during the production of this batch.Update mar08, 2018.There are no records for barrels damaged.Machinery at the different processes was verified finding no clue on where in our process could had happened.Capa not required for this event.

Event Description

It was reported that the bd posiflush¿ normal saline syringe barrel contained less than the normal liquid required for the product.Liquid was detected in the packaging flow wrap before opening the package.No reports of serious injury or medical intervention noted.

• 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: 7337703
• MDR Text Key: 102593683
• Report Number: 1911916-2018-00088
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982558
• 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: 03/02/2018

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: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7173520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2017
• 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