MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Model Number 306547

Device Problem Infusion or Flow Problem (2964)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported the pre-filled normal saline flushes are beeping ¿occluded¿ in the syringe module of the iv pump.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a syringe with no packaging flow wrap connected to an extension set.No other information can be obtained from the photo.A device history record review was completed for provided material number 306547, lot numbers 2115382, 2118976 and 2115384.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.To date, there have been no other similar events reported for these lots.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed, and without the physical sample analysis a probable root cause could not be offered.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.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2115382, medical device expiration date: 30-apr-2025, device manufacture date: 25-apr-2022, medical device lot #: 2118976 , medical device expiration date: 30-apr-2025, device manufacture date: 28-apr-2022, medical device lot #: 2115384 , medical device expiration date: 31-may-2025, device manufacture date: 25-apr-2022.

Event Description

It was reported that the bd posiflush¿ normal saline syringe experienced occluded-patient side.The following information was provided by the initial reporter: the issue my staff are reporting is a consistent error message of ¿occluded-patient side.This specifically occurs with the bd 10ml prefilled normal saline syringe.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evalution?: yes.D10: returned to manufacturer on: h6: investigation summary it was reported the pre-filled normal saline flushes are beeping ¿occluded¿ in the syringe module of the iv pump.To aid in the investigation, two empty samples, with no packaging blister or tip cap, and one photo was provided for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.Each sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.The photo shows a syringe with no packaging flow wrap connected to an extension set.No other information can be obtained from the photo.A device history record review was completed for provided material number 306547, lot numbers 2115382, 2118976 and 2115384.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.To date, there have been no other similar events reported for these lots.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed, and a probable root cause could not be offered.

Event Description

It was reported that the bd posiflush¿ normal saline syringe experienced occluded-patient side.The following information was provided by the initial reporter: the issue my staff are reporting is a consistent error message of ¿occluded-patient side.¿ this specifically occurs with the bd 10ml prefilled normal saline syringe.

• Brand Name: BD POSIFLUSH¿ NORMAL 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: 15316701
• MDR Text Key: 301989900
• Report Number: 1911916-2022-00458
• 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,Followup
• Report Date: 08/31/2022

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 Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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