MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. VAGINAL DELIVERY PACK; OBSTETRICAL KIT

Model Number DYNJ24851K

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2017

Event Type  malfunction  

Event Description

Vaginal delivery pack had 11 sponges instead of 10.Caught by nurse during counting procedure before delivery.

• Brand Name: VAGINAL DELIVERY PACK
• Type of Device: OBSTETRICAL KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6475174
• MDR Text Key: 72204462
• Report Number: 6475174
• Device Sequence Number: 1
• Product Code: OKV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2017,04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2017
• Device Model Number: DYNJ24851K
• Device Catalogue Number: DYNJ24851K
• Device Lot Number: 16YB3956
• Other Device ID Number: 93573/9926-43
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR