MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; LABOR DELIVERY PACK

Model Number DYNJ38492A

Device Problem Disconnection (1171)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/13/2022

Event Type  Injury  

Event Description

According to the facility the 'cord slipped out of the clamp when moving the baby from mom'.

Manufacturer Narrative

According to the facility the 'cord slipped out of the clamp when moving the baby from mom'.Per the facility 'the nurse was able to hold the cord and get it clamped again but there was blood loss and lab work had to be done on the baby'.The sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Type of Device: LABOR DELIVERY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14595399
• MDR Text Key: 293293562
• Report Number: 1423395-2022-00022
• Device Sequence Number: 1
• Product Code: MLS
• UDI-Device Identifier: 10888277777309
• UDI-Public: 10888277777309
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ38492A
• Device Catalogue Number: DYNJ38492A
• Device Lot Number: 21DMC975
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention