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

Catalog Number 306553

Device Problems Material Discolored (1170); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 the bd posiflush¿ sf saline syringe was yellow and discolored.Found before use.No reports of serious injury or medical intervention noted.

Event Description

It was reported that the bd posiflush¿ sf saline syringe was yellow and discolored.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: physical samples and a lot number were provided for evaluation by our quality engineer team.A device history record review did not reveal any anomalies during the production of lot number 7089735 related to the observed/reported issue.Following a thorough investigation of the returned samples, discoloration was not observed to the syringe solution or to the syringe it self, however, discoloration was observed on the product packaging.This package staining occurs as a result of the interaction between the packaging paper material and the moist heat sterilization process.Our team investigated the staining on the outer packaging and determined that this is a cosmetic issue only.The integrity of the product and the sterile barrier has not been affected.Thorough testing confirmed that the brownish spots do not present any risk to the use of the products and have no impact on the effectiveness, sterility, quality or safety of the bd posiflushtm sf 10ml saline flush syringe.Corrective action was initiated for this issue which resulted in bd changing its syringe outer package.This packaging change should effectively minimize the staining occurrence.Investigation conclusion: based on the investigation, the staining occurs as a result of the interaction between the paper and the moist heat sterilization process.Ref: pic#.: ms-003-pic.Following a thorough investigation of the returned sample, discoloration was not observed to the fluid or the syringe, however, discoloration was observed in the packaging.The staining occurs as a result of the interaction between the paper and the moist heat sterilization process.Investigation conclusion: based on the investigation, the staining occurs as a result of the interaction between the paper and the moist heat sterilization process.Ref: pic#.: ms-003-pic.Following a thorough investigation of the returned sample, discoloration was not observed to the fluid or the syringe, however, discoloration was observed in the packaging.The staining occurs as a result of the interaction between the paper and the moist heat sterilization process.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: unknown.Event attributed to: other.Device single use?: no.Device returned to manufacture: yes.

Event Description

It was reported that the bd posiflush¿ sf saline syringe was yellow and discolored.Found before use.No reports of serious injury or medical intervention noted.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7652549
• MDR Text Key: 113004084
• Report Number: 9616657-2018-00032
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: 00382903065530
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2018

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 Expiration Date: 02/29/2020
• Device Catalogue Number: 306553
• Device Lot Number: 7089735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/08/2018; 06/08/2018
• Supplement Dates FDA Received: 07/31/2018; 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other