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

Model Number	401SG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Choking (2464); Foreign Body In Patient (2687)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CONTAINER, LIQUID MEDICATION, GRADUATED
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8799213
• Report Number: 1915484-2019-01062
• Device Sequence Number: 3205834
• Product Code: KYW
• UDI-Device Identifier: 10884521140967
• UDI-Public: 10884521140967
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 401SG
• Device Catalogue Number: 401SG
• Device Lot Number: 909849X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention