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

Catalog Number 306553

Device Problem Device Packaging Compromised (2916)

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

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7180928, medical device expiration date: 2020-05-31, device manufacture date: 2017-06-29.Medical device lot #: 7013697, medical device expiration date: 2019-12-31, device manufacture date: 2017-01-13.Medical device lot #: 7038943, medical device expiration date: 2019-12-31, device manufacture date: 2017-02-07.

Event Description

It was reported that before use a bd posiflush¿ sf saline syringe was found with sterile barrier breach as "after inspecting the syringes we have and noticed that every package has a brown wet stain on the packaging which goes all the way through the packaging".There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: picture were received for evaluation.The brownish spots on the packaging were created during the steam sterilization process.Batch: 7013697, 7038943.Dhr: the non-conformances were reviewed for this batch; there were no non-conformances relating to this defect.Based on the investigation, the root cause is related to sterilization conditions.A capa has been raised to deal with the staining issue.Batch: 7180928.Dhr: the non-conformances were reviewed for this batch; there were no non-conformances relating to this defect.Based on the investigation, the staining occurs as a result of the interaction between the paper and the moist heat sterilization process.A capa has been raised to deal with the staining issues.The brown staining reported by customers, is cosmetic in nature.It is produced as a result of the interaction between the paper with the moist heat sterilization environment.The staining results in a watermark type appearance on the top web paper and has a low level of visual impact.Internal stains: bd posiflush¿ sf 10ml saline flush syringes are filled, sealed and packaged and then the package is sterilized and overwrapped with sterile material.By undergoing this process, the fluid, fluid pathway, and packaging (both inside & outside) are now sterile, thus allowing the syringe to be dropped onto a sterile field.With that being said, similar to the staining seen on the external surface of the package, brownish/yellow stains observed on the inside of the package are also a cosmetic issue only and does not present any risk to the use of the product and has no impact on the effectiveness, sterility, quality or safety of bd posiflush¿ sf 10ml saline flush syringe.Investigation conclusion: based on the investigation, the staining occurs as a result of the interaction between the paper and the moist heat sterilization process.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7484816
• MDR Text Key: 107576481
• Report Number: 9616657-2018-00019
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• 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: 05/11/2018

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 H.10
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 04/09/2018
• Supplement Dates FDA Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other