MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD ENTERAL SYRINGE WITH BD UNIVIA¿ CONNECTOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 305862

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd enteral syringe with bd univia¿ connector had a small black speck of foreign matter inside it.The following information was provided by the initial reporter: "small black speck (dust? a bug?) found inside syringe.".

Event Description

It was reported that the bd enteral syringe with bd univia¿ connector had a small black speck of foreign matter inside it.The following information was provided by the initial reporter: "small black speck (dust? a bug?) found inside syringe".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 29-dec-2022.H6: investigation summary it was reported there was a small black speck in the syringe.To aid in the investigation, one sample with no packaging blister and three photos were provided for evaluation by our quality team.A visual inspection was performed.First, with the naked eye, and then with a 10x magnifier lens.The plunger rod was removed from the syringe barrel while inspecting the parts under the magnifying lens.No defects, imperfections or foreign matter of any kind was observed.The three photos provided show a syringe with foreign matter adhered to the plunger rod.As the lot provided is 'unknown,' a device history record review could not be completed.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.However, the photos provided show a foreign matter.

• Brand Name: BD ENTERAL SYRINGE WITH BD UNIVIA¿ CONNECTOR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 16057812
• MDR Text Key: 308475733
• Report Number: 1911916-2022-00779
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112434
• 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,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305862
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• 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