MAUDE Adverse Event Report: COVIDIEN 1ML PURPLE ORAL SYRINGE STRL; CONTAINER, LIQUID MEDICATION, GRADUATED

Model Number 401SG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Choking (2464); Foreign Body In Patient (2687)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation because it was discarded, therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that they used the product in the newborn nursery to reserve the mother's breast milk in refrigerator until it was ready to feed per hospital protocol.The father of the patient retrieved the syringe to feed the baby unaware of the cap on the tip of the syringe.When the father squeezed the milk into the baby's mouth it caused the cap to become lodged in the baby's throat resulting in choking.Emergency choking procedures were undertaken, which included back blows and chest compressions for about a minute.The patient is now doing well.

• Brand Name: 1ML PURPLE ORAL SYRINGE STRL
• Type of Device: CONTAINER, LIQUID MEDICATION, GRADUATED
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 8799213
• MDR Text Key: 151334013
• Report Number: 1915484-2019-01062
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 10884521140967
• UDI-Public: 10884521140967
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 401SG
• Device Catalogue Number: 401SG
• Device Lot Number: 909849X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention