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

Catalog Number 306546

Device Problem Material Separation (1562)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H6: investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.H3: see h.10.

Event Description

It was reported while using bd posiflush¿ normal saline syringes the device was damaged.This occurred 100 times.There was no report of patient impact.The following information was provided by the initial reporter: origin of the issue: product failure//design.Detail: user's department: supply chain material manager information: material manager name: xxx material manager email: xxx@slhs.Org material manager phone:xxx material manager fax: material manager location: , issue information: quality issue is for: supply item type of issue: product failure/design nature of issue: nursing product information: product description: 10 ml normal saline flush product catalog number: 306546 product lot number: manufacturer name: bd supplier name: concordance other information: number of occurrences:100 is sample available: no reported to vendor representative: yes please contact before closing issue: false detailed description of issue: the rubber stopper has a screw-on type connection to the plunger.It is national standards to use the saline flush in a push-pull method.This connection is not made to withstand the pressure of pulling and pushing blood.The rubber stopper is separating from the plunger into the syringe of blood.Number of occurrences: 100.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGES,
• 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: 16943477
• MDR Text Key: 315373351
• Report Number: 1911916-2023-00312
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• 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
• Report Date: 04/26/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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