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

Model Number	DYNJ38492A
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility the 'cord slipped out of the clamp when moving the baby from mom'.
Additional 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.
• Common Device Name: 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
• Report Number: 1423395-2022-00022
• Device Sequence Number: 2058604
• Product Code: MLS
• UDI-Device Identifier: 10888277777309
• UDI-Public: 10888277777309
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: Health Professional
• Device Model Number: DYNJ38492A
• Device Catalogue Number: DYNJ38492A
• Device Lot Number: 21DMC975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown