MAUDE Adverse Event Report: SAGE PRODUCTS, LLC UNKNOWN; SUCTION SWAB

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Report received of a user error resulting in a suction swab disengagement.Reporter stated that on (b)(6) 2014, pt had a scheduled esophagogastroduodenoscopy (egd) the reason for procedure was unk by reporter.During the esg, an object described as a portion of green foam with a small white plastic tube in the center was noted in the pt's stomach.Reporter identified the object as the tip of a sage suction swab.Reporter stated the object was removed so that it would not obstruct the drainage flow of pt's nasogastric tube.Reporter stated upon viewing object, it was evident the pt had bitten off the tip of the suction swab.Reporter described involved pt as confused, disoriented, uncooperative with a history of biting.Reporter indicated that while hospitalized, there was no report of the pt biting off a suction swab.Reporter stated she was certain incident occurred in pt's home prior to hospitalization although the family never mentioned that fact, when asked about the lot number, expiration date, and scu number, as reported on form 3500, reporter stated she did not know the details from what kit the swab came.Reporter explained she selected a sage brand #(b)(4) q4 complete care kit from the storeroom, as it contained suction swabs, and completed section e of the form 3500 using that kit's lot number, expiration date, and scu.She did not inquire of the family about the brand of product used at home.Through requested, no additional info was available.

Manufacturer Narrative

Reporter declined request to return object for eval, although provided two photographs.Though reporter identified object as a sage suction swab, no model number, catalog number, or lot info was available.Eval of the photographs indicates the reported event is not attributable to a product defect and/or manufacturing operations.Eval of the photographs is consistent with reporter's statement that the object, which appears to be the tip of a suction swab, was bitten off by the pt.The packaging label contains precautionary statements advising the end user to use a bite block when performing oral care on pts with altered levels of consciousness, or those who cannot comprehend commands, and ensuring the foam head is intact.User facility report form fda 3500 received and reviewed.Provided on this form is additional, corrected, and missing info related to the reported event.Info was obtained after speaking with initial reporter.(b)(4).

• Brand Name: UNKNOWN
• Type of Device: SUCTION SWAB
• Manufacturer (Section D): SAGE PRODUCTS, LLC; cary IL
• Manufacturer Contact: denise hummel, rn, bsn ; 3909 three oaks rd; cary, IL 60013 ; 8003232220
• MDR Report Key: 3880655
• MDR Text Key: 4458866
• Report Number: 1419181-2014-00001
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ENDOTRACHIAL TUBE; NASOGASTRIC TUBE
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR