MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Illegible Information (4050)

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

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9113775.Medical device expiration date: 2022-04-30.Device manufacture date: 2019-04-23.Medical device lot #: 9113796.Medical device expiration date: 2022-04-30.Device manufacture date: 2019-04-23.Medical device lot #: 9078608.Medical device expiration date: 2022-02-28.Device manufacture date: 2019-03-19.Medical device lot #: 9150587.Medical device expiration date: 2022-05-31.Device manufacture date: 2019-05-30.Medical device lot #: 9161930 medical device expiration date: 2022-05-31 device manufacture date: 2019-06-10 investigation summary: one photo was provided.The photo shows two syringes with their barrel labels.One of the syringe barrel labels has a bar code with a black area towards the upper right side of the bar code.The batch records have a sample of the barrel label and the proof they were scanned and readable.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the first complaint for lots # 9161930, 9078608, 9150587, 9113796, 9113775 for this type of defect or symptom.There was no documentation of issues for the complaint of lots # 9161930, 9078608, 9150587, 9113796, 9113775 during this production run.Root cause description: bd was unable to replicate the failure.

Event Description

It was reported that an unspecified number of syr 10ml pump compatible saline 10ml fil experienced label or package smearing/print permanency illegible which was noted prior to use.The following information was provided by the initial reporter: material no: 306547, batch no: 9161930, 9078608, 9150587, 9113796, 9113775.Event details: nursing is reporting a line running through the bar codes and are unable to read.This is affecting multiple lot #.9161930, 9078608, 9150587, 9113796, and 9113775.Unable to scan bar code.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• Type of Device: SALINE, VASCULAR ACCESS 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 ; 8015652341
• MDR Report Key: 8939501
• MDR Text Key: 156030337
• Report Number: 1911916-2019-00869
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

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 Catalogue Number: 306547
• Device Lot Number: SEE H.10
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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