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

Catalog Number 306565

Device Problems Component Missing (2306); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Investigation: return samples received: yes, photo received.Return sample showed: photo showed reported defect yes dhr/bhr review there was no documentation of the issue identified in the complaint during this production run for batch 6357653.Conclusion: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure mode investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Random test was done 3 separate times to check the camera was working properly and all syringes with the missing label was rejected to waste.Update 8/30/2017.A picture was received.It shows a syringe out of the flow wrap packaging.It has tip cap, it looks full of solution and has the rubber stopper and plunger rod.The sample shown in the picture doesn¿t have barrel label.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 were no issues documented about any type of barrel label missing.(b)(6).(b)(4).

Event Description

It was reported that a bd posiflush¿ saline 10ml syringe was missing scale markings.Found before use.No report of serious injury or medical intervention given.

• Brand Name: BD POSIFLUSH¿ SALINE 10ML SYRINGE FILLED
• 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: 6848846
• MDR Text Key: 85610906
• Report Number: 1911916-2017-00217
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K982558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2017

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: 12/31/2019
• Device Catalogue Number: 306565
• Device Lot Number: 6357653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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