MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 5 ML BD POSIFLUSH¿ SP; SALINE FLUSH

Catalog Number 306574

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).Investigation: a sample was received.The sample has an opened packaging flow wrap.It has the tip cap, the plunger rod- stopper and solution in it.The barrel label confirms the lot# 7075611.The sample received doesn¿t show the reported issue: discoloration/ variation in color/ cloudy.It was most likely sent as a sample for the lot#, not for the issue; as stated in the complaint report the customer didn¿t keep the actual sample.There were no issues documented during the production of this batch for discoloration/variation in color/cloudy.All our inspections performed while manufacturing this batch were accepted.No rejections were documented.Root cause could not be determined.

Event Description

It was reported that the customer received some 5 ml bd posiflush¿ sp that were missing labels and others were cloudy.This was noticed before use and there was no report of injury or medical interventions.

• Brand Name: 5 ML BD POSIFLUSH¿ SP
• 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: 7011840
• MDR Text Key: 92773262
• Report Number: 1911916-2017-00302
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 306574
• Device Lot Number: 7075611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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