MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported that prior to use with 2 bd posiflush¿ normal saline syringe, in 10 ml syringe is found damaged.The following information was provided by the initial reporter: the customer complained that the syringe is found damaged.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09mar2023.H6: investigation summary ithe following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09mar2023.H6: investigation summary it was reported the unit was received damaged.To aid in the investigation, one empty sample with no packaging blister and three photos were provided for evaluation by our quality team.A visual inspection was performed and unit is damaged.No other defects or imperfections were observed.The three photos provided show the sample received.This defect could occur if there was a jam at the station where the syringe barrel labels, and plunger rods are assembled.A device history record review was completed for provided material number 306546, lot 2172130.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 process where the syringe barrel label and plunger rods are assembled was performed.The settings were correct, and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.

Event Description

It was reported that prior to use with 2 bd posiflush¿ normal saline syringe, in 10 ml syringe is found damaged.The following information was provided by the initial reporter: the customer complained that the syringe is found damaged.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML 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 ; 8448235433
• MDR Report Key: 16441176
• MDR Text Key: 310437220
• Report Number: 1911916-2023-00104
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

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: 306546
• Device Lot Number: 2172130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/26/2023
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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