MAUDE Adverse Event Report: HOSPIRA SODIUM CHLORIDE 0.9% INJECTION USP

Catalog Number 0409-7983-03

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 06/27/2014

Event Type  Injury  

Event Description

Normal saline bag in 500ml from the pt's arterial line was found with small leak along the seam of the bag adjacent to the administration port.Icu staff removed the bag with the leak, sequestered, labeled and returned it to central supply for investigation.Clinical interventions were effective in preventing harm to pt.This action happened after nih cc issued a house wide alert to hcp that they should be aware of reports of small leaks in the same lot number of bags noted earlier by the anesthesiologists in surgery.On (b)(6) 2014, anesthesiologist reported to nurse consultant in central supply that multiple bags of normal saline bags, 07983, lot 38 503 fw, had small leaks in the same location - edge where the bag is spiked not associated with user error.Six bags with problems but only one bag was saved.Event reported to mfr (hospira) on (b)(6) 2014 and bag returned to hospira.Hospira responded with comments, (b)(4).On (b)(4) 2014, (b)(4) issued house wide alert advising staff to be aware of potential problem and what actions to take if they discovered normal saline bags with leaks.On (b)(6) 2014, icu reported two bags of normal saline 0.9% with same issue, leak along the seam of the bag near the injection port.One bag was saved and returned to central supply.Lot #38503 fw - 07983.(b)(6) reported event to hospira (b)(4) and returned the bag to mfr.On (b)(4) 2014, hospira sent (b)(6) a request for add'l info on (b)(6).(b)(6) not complete (b)(4) but elected to submit problem product report 3500 to fda.On (b)(4) 2014, (b)(6) submitted product problem report form 3500 to the fda and mfr.Hospital personnel remain vigilant in checking bags for leaks and are competent to implement clinical interventions.(b)(6) will report to fda and hospira if event reoccurs.Diagnosis or reason for use: maintain arterial line patency.Event abated after use stopped or dose reduced: yes.

• Brand Name: SODIUM CHLORIDE 0.9% INJECTION USP
• Type of Device: INJECTION
• Manufacturer (Section D): HOSPIRA
• MDR Report Key: 3944639
• MDR Text Key: 15182031
• Report Number: MW5037289
• Device Sequence Number: 1
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: 0409-7983-03
• Device Lot Number: 38-503 FW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention