MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO JACKSON-PRATT 100CC BULB RESERVOIR; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-1305
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was received and forwarded to the manufacturing facility for investigation.The customer sample was not returned for evaluation.It is vital to the investigation that the customer sample be available for examination and testing.As no lot number was provided, we were unable to trace the device history record (dhr), quality testing performed and corresponding results.The non-conformance report (ncr) data since november 2017 to present was reviewed and no issues that could be related to the condition reported were found.Root cause for the reported concern cannot be identified with the amount of information available.No actions identified, since no evidence of a manufacturing issue was found.We will continue to monitor trends and utilize the information as part of continuous improvement.
Event or Problem Description
We have had suctioning issues with the bulb.One patient that ended up with free air in the abdomen was returned to surgery about 12 hours after the surgical procedure, but is fine now.The free air in the abdomen was confirmed by xray and ct scan.I am not sure if it is a nursing error or the bulbs themselves.

• Brand Name: JACKSON-PRATT 100CC BULB RESERVOIR
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• MDR Report Key: 8211919
• Report Number: 1423537-2019-00249
• Device Sequence Number: 18901294
• Product Code: GCY
• UDI-Device Identifier: 10885380061493
• UDI-Public: 10885380061493
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: SU130-1305
• Device Catalogue Number: SU130-1305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention