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

Catalog Number 306595

Device Problems Break (1069); Device Damaged Prior to Use (2284)

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

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary three samples were received by bd for evaluation.A quality engineer was able to inspect the returned samples regarding the issue of barrel/flange damage.The engineer found that all three syringes had damaged flanges thus verifying the reported issue.The most probable cause for this event was a variation with the plunger rod labeler.The engineer made any necessary adjustments to the machine and verified that it was working properly.A review of the device history record for the reported lot revealed zero defects found 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 investigation conclusion dhr/bhr review: there was no documentation of issues for the complaint of batch 7208540 during this production run.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Update jun07, 2018.Three (3) samples were received.They do not have the packaging flow wrap.They all have the plunger rod-rubber stopper, tip cap and saline solution, the barrel label confirms the lot# 7208540.The three (3) have the flange damaged.Product within specification? yes? no? 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 nor cracked barrel.Capa (b)(4) has been opened.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Update jun07, 2018.Three (3) samples were received.They do not have the packaging flow wrap.They all have the plunger rod-rubber stopper, tip cap and saline solution, the barrel label confirms the lot# 7208540.The three (3) have the flange damaged.Product within specification? yes? no? 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 was no issue documented about barrel/flange damaged nor cracked barrel.Update 07jun2018: most probable cause was determined to be a variation to the plunger rod labeler.

Event Description

It was reported that before use a bd posiflush¿ normal saline syringe was found by the nurse with "flange broken when opened the unit package." there was no report of exposure, injury or medical intervention needed.

• 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: 7603148
• MDR Text Key: 111710126
• Report Number: 1911916-2018-00285
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7208540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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