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

Catalog Number 306595

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Six samples were received at the manufacturing plant for evaluation.A quality engineer was able to inspect the samples and determined that all six samples displayed barrel/flange damage.A possible root cause was found to be a variation with the plunger rod labeler.The labeler was inspected and any adjustments were made.It was verified to be working properly.A device history record was performed on the reported batch and determined that zero defects were found during production.Dhr/bhr review: there was no documentation of issues for the complaint of batch 7208541 during this production run.Investigation comments: all our inspections and testing performed while manufacturing this batch were accepted.No rejections were documented.Update apr 06, 2018.Six (6) samples were received all samples have the sealed packaging flow wrap, the plunger rod-rubber stopper, the tip cap and saline solution; the barrel labels confirm the lot#7208541.All six (6) samples have the barrel 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 and testing were accepted during the production of this batch.Possible root cause.Possible the plunger rod labeler equipment experienced a variation; anyway, adjustments have been verified.Capa not required for this event.

Event Description

It was reported that the flange of a 10 ml bd posiflush¿ normal saline syringe was broken, before use.There was no report of exposure, 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: 7421762
• MDR Text Key: 105400982
• Report Number: 1911916-2018-00140
• 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: 03/28/2018

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: Nurse
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7208541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/11/2018
• 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