MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306565

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported the syringe presents discoloration in the protector that is in the syringe tip.To aid in the investigation, two samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed and the tip cap has discoloration that was not possible to remove with an alcohol wipe; it appears to be lubricant from the molding process.Because it is very thin, it is not possible to perform additional ftir testing.No other defects or imperfections were observed.It could be possible, during the molding process, some residues of lubricant were left and got onto the tip caps.A device history record review was completed for provided material number 306565, lot number 1263948.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the molding process was performed.The molding press and tool were clean.No residues of lubricant or any other material that could induce the symptom reported was observed.The samples will be shown to the associates for awareness.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported by the customer that during use the 10ml bd posiflush¿ sterile field (sf) saline syringe presents discoloration in the protector that is in the syringe tip.The following information was provided by the initial reporter: "by this means, i would like to inform you that we have a possible quality problem with the following deviation: syringe prefilled with saline solution 0.9% 10 ml ref (b)(4) lot: 1263948, it presents discoloration in the protector that is in the syringe tip.".

• Brand Name: 10ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14712039
• MDR Text Key: 294529013
• Report Number: 1911916-2022-00299
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306565
• Device Lot Number: 1263948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1