MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE ORAL 50ML CLEAR STERILE; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number 305863

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, one photo was provided.It shows a packaging blister top web however, it does not show the symptom and product reported.As a sample was unavailable for return, a thorough sample investigation could not be completed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure with the photo provided.Root cause description: based on the investigation results, an exact cause for this incident could not be identified.Rationale: further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

Event Description

It was reported that there were no scale markings on the syringe oral 50ml clear sterile.The following information was provided by the initial reporter: "it was reported that the markings on syringe are missing." date: (b)(6) 2020 at 3 pm, harm: no harm, department: nicu/supply chain, reported by: rn, product description: bd 50 ml oral/enteral syringe.Enternal feeding syringe utilized in the nicu.

• Brand Name: SYRINGE ORAL 50ML CLEAR STERILE
• Type of Device: GASTROINTESTINAL TUBE 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10841528
• MDR Text Key: 217714277
• Report Number: 1911916-2020-01030
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 30382903058632
• UDI-Public: 30382903058632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112434
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 305863
• Device Catalogue Number: 305863
• Device Lot Number: 9316305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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