MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE; SALINE FLUSH

Catalog Number 306553

Device Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Four potential lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 7244896, medical device expiration date: 08/31/2020, device manufacture date: 09/01/2017.Medical device lot #: 7277539, medical device expiration date: 09/30/2020, device manufacture date: 10/04/2017.Medical device lot #: 7319531, medical device expiration date: 10/31/2020, device manufacture date: 11/15/2017.Medical device lot #: 7348816, medical device expiration date: 11/30/2020, device manufacture date: 12/14/2017.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a ¿yellow stain¿ was found on several 10 ml bd posiflush¿ sf saline syringe packagings.The stains were reported to seep through the packaging.In addition, it was reported one of the products were "opened and bubbling" occurred.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: picture samples were received for evaluation by our quality engineer team for the defects of package stains and bubbling of the barrel label.Package staining: capa(b)(4) has been raised following unit level discussions in (b)(6) 2017.The following testing was done in connection to the capa.Since physical samples were not returned for this complaint the information is used for reference only.The discoloration of the package material has been determined cosmetic only.These products are safe for use.The integrity of the product and the sterile barriers has not been affected.The brownish spots on the packaging were created during the steam sterilization process.Microbial permeability testing, cytotoxicity testing, and testing for residual solvents and volatile species has been completed on the packages displaying the brownish stains.The testing confirmed that they do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality or safety of bd posiflushtm sf 10ml saline flush syringe.Proper personnel have been working on a solution to eliminate the brown staining occurrence.Through examination of the picture samples, the defect of bubbling under the barrel label was observed.The bubbling was determined to be associated with an isolated incident in the label application process.This issue is cosmetic only and there is no impact to the product safety or functionality.Root cause for discoloration defect: based on the investigation of the reported issue, the root cause is determined to be related to the sterilization process.The staining occurs as a result of the interaction between the paper and the moist heat sterilization process.Root cause for the bubbling defect: a single root cause is not assignable in this case, it is associated with an isolated incident in the label application process.The issue is cosmetic only and there is no impact to the product safety or functionality.Dhr: there were no non-conformances associated with this failure mode for the lot numbers listed in connection with this complaint.Other actions taken: each step in the manufacturing process is highly controlled, monitored, and documented to ensure the highest quality of our products.Bd continuously assesses our manufacturing process to ensure product quality.Complaints received for this device and reported conditions will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly through quality data analysis and quarterly through management review.

• Brand Name: 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7298090
• MDR Text Key: 101153073
• Report Number: 9616657-2018-00005
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K042061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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: Other
• Device Catalogue Number: 306553
• Device Lot Number: SEE SECTION H.10.
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other