MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER ABBVIE J; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 062918-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Bowel Perforation (2668)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).The device manufacturer and lot number of the intestinal tube involved in this event was not provided by the complainant.Therefore, it is unknown if the tubing involved was the abbvie j tube.Abbvie has chosen to report this event due to the potential that the intestinal tube involved could have been the abbvie j tube.The device involved in the event was not returned for evaluation, it was discarded; therefore a return sample evaluation was not performed.Intestinal perforation is a known complication of device placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2018, patient in (b)(6) was hospitalized for an intestinal tube replacement.On (b)(6) 2018, it was reported that the procedure was postponed.After an unspecified period of time, the intestinal tube was replaced.It was reported that during the intestinal tube replacement, the small intestine was perforated and the patient was admitted to intensive care unit.On (b)(6) 2019, the patient died due to small intestine perforation.Though requested, no additional information was provided.

• Brand Name: ABBVIE J
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer (Section G): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer Contact: terry ingram ; 1675 lakeside drive; waukegan, IL 60085 ; 8479385350
• MDR Report Key: 8280115
• MDR Text Key: 134175030
• Report Number: 3010757606-2019-00060
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 062918-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR