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	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer sample was not available for evaluation.It is vital to the investigation that the customer sample be available for examination and testing.Since no lot number was provided, we were unable to review the device history record (dhr), quality testing performed and corresponding results.The non-conformance report (ncr) data since (b)(6) 2018 to present was reviewed and no issues that could be related to the condition reported were found.An analysis of the complaint data was also reviewed for the same time period and demonstrates that this is the first time that this type of issue is reported from on this catalog number in the last 12 months.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
Jp drain frayed while being removed from the patient's head.There were no retained objects in the patient's head when the physician took the patient back to surgery.Patient has no infectious diseases.

• 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: 8742052
• Report Number: 1423537-2019-00330
• Device Sequence Number: 2155133
• Product Code: GCY
• UDI-Device Identifier: 10885380061493
• UDI-Public: 10885380061493
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention